[Senate Hearing 110-1248]
[From the U.S. Government Publishing Office]






                                                       S. Hrg. 110-1248


                            OVERSIGHT ON EPA
                        TOXIC CHEMICAL POLICIES

=======================================================================

                                HEARING

                               before the

                              COMMITTEE ON
                      ENVIRONMENT AND PUBLIC WORKS
                          UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                             APRIL 29, 2008

                               __________

  Printed for the use of the Committee on Environment and Public Works






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               COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                       ONE HUNDRED TENTH CONGRESS
                             SECOND SESSION

                  BARBARA BOXER, California, Chairman
MAX BAUCUS, Montana                  JAMES M. INHOFE, Oklahoma
JOSEPH I. LIEBERMAN, Connecticut     JOHN W. WARNER, Virginia
THOMAS R. CARPER, Delaware           GEORGE V. VOINOVICH, Ohio
HILLARY RODHAM CLINTON, New York     JOHNNY ISAKSON, Georgia
FRANK R. LAUTENBERG, New Jersey      DAVID VITTER, Louisiana
BENJAMIN L. CARDIN, Maryland         JOHN BARRASSO, Wyoming
BERNARD SANDERS, Vermont             LARRY E. CRAIG, Idaho
AMY KLOBUCHAR, Minnesota             LAMAR ALEXANDER, Tennessee
SHELDON WHITEHOUSE, Rhode Island     CHRISTOPHER S. BOND, Missouri

       Bettina Poirier, Majority Staff Director and Chief Counsel
                Andrew Wheeler, Minority Staff Director

















                            C O N T E N T S

                              ----------                              
                                                                   Page

                             APRIL 29, 2008
                           OPENING STATEMENTS

Boxer, Hon. Barbara, U.S. Senator from the State of California...     1
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma...     3
Lautenberg, Hon. Frank, U.S. Senator from the State of New Jersey     9
Hon. John A. Barrasso, U.S. Senator from the State of Wyoming....    10
Whitehouse, Hon. Sheldon, U.S. Senator from the State of Rhode 
  Island.........................................................    12
Craig, Hon. Larry E , U.S. Senator from the State of Idaho.......    13
Cardin, Hon. Benjamin L., U.S. Senator from the State of Maryland   167

                               WITNESSES

Gulliford, Hon. James, Assistant Administrator for Prevention, 
  Pesticides, And Toxic Substances, U.S. Environmental Protection 
  Agency.........................................................    16
    Prepared statement...........................................    19
Stephenson, John B., Director, Natural Resources and Environment, 
  U.S. Government Accountability Office..........................    26
    Prepared statement...........................................    28
Giudice, Linda C., M.D., Ph.D., MSc., Professor and Chair, 
  Department of Obstetrics, Gynecology and Reproductive Sciences, 
  University of California, San Francisco........................    73
    Prepared statement...........................................    75
    Responses to additional questions from Senator Boxer.........   100
Gellert, Annette, Co-Founder, Chair, Well Network................   102
    Prepared statement...........................................   104
DeLisi, V.M., President, Fanwood Chemical, Inc...................   116
    Prepared statement...........................................   119
Plunkett, Laura M., Ph.D., DABT, Integrative Biostrategies, LLC..   124
    Prepared statement...........................................   127
    Response to an additional question from Senator Boxer........   150
    Response to an additional question from Senator Inhofe.......   150
Goldman, Lynn R., M.D., M.P.H., Professor, Environmental Health 
  Sciences, Johns Hopkins University, Bloomberg School of Public 
  Health.........................................................   151
    Prepared statement...........................................   154

                          ADDITIONAL MATERIAL

Statements
    American Chemistry Council...................................   169
    Integrative Biostrategies, LLC...............................   180
Articles
    Prostate Cancer; David F. Penson, June M. Chan, and the 
      Urologic Diseases in America Project.......................   183
    Testis Cancer; Mitchell H. Sokoloff, Geoffrey F. Joyce, 
      Matthew Wise and the Urologic Diseases in America Project..   252
    Trends in testicular cancer incidene and mortality in 22 
      European countries: Continuing increases in incidence and 
      declines in mortality......................................   264

 
                           OVERSIGHT ON EPA 
                        TOXIC CHEMICAL POLICIES

                              ----------                              


                        TUESDAY, APRIL 29, 2008

                                       U.S. Senate,
                 Committee on Environment and Public Works,
                                                    Washington, DC.
    The full committee met, pursuant to notice, at 10 a.m. in 
room 406, Dirksen Senate Office Building, Hon. Barbara Boxer 
(chairman of the full committee) Presiding.
    Present: Senators Boxer, Inhofe, Lautenberg, Klobuchar, 
Whitehouse, Barrasso, Craig

           OPENING STATEMENT OF HON. BARBARA BOXER, 
           U.S. SENATOR FROM THE STATE OF CALIFORNIA

    Senator Boxer. The Committee shall come to order. We 
welcome our panel and our honored guests who are here today.
    Today we will hear about the risks that toxic chemicals 
pose to our families and communities. Most at risk are 
children, pregnant women, the elderly and those who are ill. We 
will also hear some disturbing news about the White House and 
the Bush administration's efforts to corrupt EPA's toxic 
chemical risk assessment process. By placing politics before 
science, the Bush administration is putting the public in 
harm's way, this according to the GAO and EPA scientists.
    A close look at the EPA's toxic chemical policies makes 
clear that improvement is necessary if we are to ensure that 
dangerous chemicals are properly regulated. EPA regulates toxic 
chemicals in the environment under several laws. The overall 
toxic chemicals law, the Toxic Substances Control Act, or TSCA, 
was adopted in 1976 and was supposed to help assure that toxic 
chemicals would be restricted or banned if they were hazardous.
    But in essence, TSCA puts the burden on the Government to 
prove a toxic chemical is a risk. That is unlike the European 
program, called REACH. REACH puts the burden on the chemical 
industry, where it should be, to show that chemicals are safe.
    In implementing TSCA and other laws like the Clean Air Act, 
the Safe Drinking Water Act and Superfund, EPA relies on risk 
assessments which evaluate how toxic a chemical is and to what 
extent people are exposed to it. In 1985, EPA developed a 
system called the Integrated Risk Information System, or IRIS, 
which establishes safe levels for toxic chemicals. The levels 
set in IRIS are used as the scientific foundation for most EPA 
regulatory programs and for many State programs to establish 
health standards for air and water pollution, waste cleanup and 
other programs. For example, the levels set for arsenic in our 
water and benzene in our air went through the IRIS system.
    Early in the Bush administration, the White House insisted 
on changing EPA does risk assessments. What they did is, they 
wanted to bring OMB, the Office of Management and Budget, and 
other agencies more directly into the process. Soon after EPA 
Administrator Johnson took over the agency in May 2005, he made 
changing IRIS and risk assessment a high priority. The GAO 
report I am releasing today criticizes the Bush administration 
changes to the risk assessment process and makes it clear that 
the danger faced by the public, when political interference and 
influence of polluters is paramount, is serious.
    Under EPA's new approach, politics can be and already has 
been injected into multiple stages in the process. Now, no one 
can explain to me where there is room for politics when you are 
looking at the health and safety of the American people. Even 
worse, the new procedure effectively requires the White House, 
the Department of Defense, which contracts out much of its 
weapons programs, to agree with EPA on any risk assessment 
before it goes forward and before it is made public. So instead 
of having the scientists at EPA decide what is good for our 
health, we now have contractors essentially at the table. And 
we have the private sector and those with the special interests 
effectively at the table.
    What makes it worse is, the entire process is kept secret, 
which GAO and EPA scientists say undermines the credibility of 
EPA's scientific assessments. That is because EPA scientists 
are being pushed aside by White House operatives and polluters. 
According to the GAO, the EPA's flawed risk assessment process 
essentially derailed the risk assessment for TCE, a solvent 
that is the most common organic groundwater contaminant in the 
U.S. TCE causes cancer, including childhood cancer, and birth 
defects. EPA's assessment for naphthalene, a component of jet 
fuel that the National Toxicology Program has found ``can 
reasonably be anticipated to be a human carcinogen'' has also 
been derailed. Naphthalene contaminates at least 654 Superfund 
National Priority List sites and many DOD facilities. GAO found 
that ``DOD could face extensive cleanup costs'' if naphthalene 
is more strictly controlled.
    And here is the irony for me. This Administration has no 
end in sight for funding of the Department of Defense. And the 
Department of Defense protects us all over the world. Isn't it 
ironic, while they are doing that, they are derailing defenses 
against toxic chemicals? To me, it is the ultimate irony.
    Similarly, GAO found extraordinary delays in the risk 
assessment process for formaldehyde--you have heard of 
formaldehyde--a chemical in plywood and many consumer products 
that has been linked to leukemia and other cancers. An EPA 
scientist with extensive knowledge of this program told our 
Committee staff that the Bush administration's risk assessment 
process could have ``a significant impact on public health by 
delaying decisions so exposures can continue unabated to 
carcinogens, chemicals that cause birth defects and 
developmental effects, neurotoxic effects,
    [so] a lot of people are affected.''
    This isn't about affecting a few people. This is about 
affecting our people in a broad way. And how many of us have 
said, children are our future?
    This scientist also reported to us that ``de facto, EPA 
can't go forward'' without White House, DOD and other agency 
sign-off. The process has, according to this knowledgeable 
expert, put the scientists aside and has been ``taken over by 
the White House,'' his words.
    EPA's mission is to protect public health and our 
environment. Politics must never play a role when it comes to 
protecting our families. But as GAO has found, the series of 
delays has ``limited EPA's ability to conduct its mission,'' 
and that is a direct quote from the GAO report.
    The role of independent scientists at EPA must be restored 
so that EPA can carry out its mission without secret 
interference. We must also strengthen our toxics laws to ensure 
that chemical companies are responsible for proving that their 
products are safe, including safe for pregnant women, children, 
the elderly and others who are most vulnerable to toxic 
chemicals.
    I so look forward to this hearing and hearing from our 
witnesses on this critical topic. And if you could give Senator 
Inhofe seven and a half minutes, please.

          OPENING STATEMENT OF HON. JAMES M. INHOFE, 
            U.S. SENATOR FROM THE STATE OF OKLAHOMA

    Senator Inhofe. Thank you, Madam Chairman. I don't need 
seven and a half minutes. I regret that I won't be able to stay 
here for the whole hearing.
    Today's hearing concerns me for several reasons. First, it 
was called to take a look at EPA's chemical program under TSCA, 
at least that is what we were told and I think that is what the 
EPA was told. However, it now appears that a major part of the 
focus is on the changes in the IRIS program. Unfortunately, the 
witness whom the Chairman invited from the EPA, Assistant 
Administrator Gulliford, who runs the TSCA program, Assistant 
Administrator Gray runs the IRIS program. So Mr. Gulliford, 
while you might be able to offer some general comments on the 
IRIS program, you should not be expected to be the expert that 
you are in your own field.
    Next, my staff was repeatedly told by the majority staff 
that GAO was working on an IRIS report, but they weren't sure 
if it would be ready in time. This report, in keeping with our 
Committee rules, was distributed on Friday. However, we now 
understand that not only was the report completed by March 7th, 
but it was Senator Boxer's office that requested that the GAO 
embargo the report for 30 days. While this is occasionally 
done, Senator Boxer's deputy staff director went even further 
to request that the embargo be extended until this hearing. 
This is not a common practice and I have a letter from the GAO 
that I would like to enter into the record at this time.
    Senator Boxer. Without objection, so ordered.
    [The referenced material follows:]



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    Senator Inhofe. My concern in all this, inviting the wrong 
EPA witness, withholding from the minority the GAO report for 
more than 50 days, is that this hearing today appears to be set 
up as a ``gotcha'' hearing to try to embarrass the 
Administration, instead of a legitimate oversight hearing. If 
the Chairman were truly concerned about oversight and changing 
policy, then she would have shared the report when it became 
available over a month and a half ago, and she would have 
invited the correct EPA witness. I understand at one point she 
wanted the Administrator, but she invited the TSCA Assistant 
Administrator.
    Oversight works best when it is done in the open. By not 
disclosing the true intent of today's hearings to the agency 
and the minority, we are left with, at best, an incomplete and 
inconclusive attempt at oversight.
    I believe we need to work together on oversight, such as a 
hearing examining the ethanol program. This Committee has not 
held such a hearing, despite massive changes in the law last 
year, which has increased food prices contributing to riots. 
And by the way, I would like to make that as an official 
request. I am going to be on the floor today, Madam Chairman, 
at some length, talking about the mandates, the ethanol 
mandates and how they relate to the cost of food stocks. In 
fact, this is an area where I will be in concert with what 
normally are not my best friends on the environmental issues. 
It is something I think you agree with, that I think we need to 
determine, be concerned about this diversion of these to fuel 
from food.
    So I would like to make that request, I think we should 
have that. I will be more elaborate on the floor in talking 
about this, I have about a 1-hour speech on the ethanol mandate 
and how much that is hurting a lot of people.
    Thank you, Madam Chairman.
    [The prepared statement of Senator Inhofe follows:]

             Statement of Hon. James Inhofe, U.S. Senator 
                       from the State of Oklahoma

    Good morning. Today's hearing is to examine the adequacy of 
the mechanisms for the evaluation and regulation of chemicals 
by the EPA. The subject is important because the chemical 
industry is a crucial part of the US economy and we have to be 
mindful of what we put at risk if we over-regulate this 
industry and stifle its 30 year history of innovation.
    Here are some statistics. The United States is the No. 1 
chemical producer in the world, generating $635 billion a year 
and putting more than 5 million people to work. The US chemical 
industry paid more than $27.8 billion in Federal, State and 
local income taxes in 2006. More than 96 percent of all 
manufactured goods are directly touched by chemistry.
    But it is about more than money. Chemicals are the 
essential building blocks of products that safely and 
effectively prevent, treat and cure disease; ensure the safest 
and most abundant food supply in the world; purify our drinking 
water and put out fires. They are the foundation for life-
saving medical devices, such as sutures, internal tubing, and 
scalpels. Innovations in chemistry have made planes, fighter 
jets, and space shuttles safer and more secure. Plastics are 
used to make lighter, yet stronger, cars and silica is an 
ingredient in low-rolling resistance tires, all of which 
increases automobile fuel efficiency. Alternative sources of 
energy, on which cap and trade proponents are relying, are 
dependent on chemicals. Wind power blades contain polyester and 
resin additives and solar power relies on silicon-based 
materials. Finally, chemicals keep our children and our men and 
women in uniform safe by increasing the effectiveness of child 
safety seats, bicycle helmets, and Kevlar vests. I could go on 
and on.
    The reason I point all this out is that there are many 
people who come to this hearing with a belief that the US 
chemicals management program is broken and that Congress needs 
to completely rewrite the Toxic Substance Control Act 
(pronounced TOS-KA). I do not agree.
    For nearly 30 years, chemical products have been among the 
most thoroughly evaluated and regulated, covered by more than a 
dozen Federal laws, including TSCA. These statutes call for 
regulation of chemicals based on risk. I do not believe 
American chemicals innovation should be stifled by government 
regulation without the clear identification of risk. We need to 
ensure that we regulate chemicals based on demonstrated risk 
not the just the perception or assumption of it. That 
``precautionary'' concept is one that I cannot support.
    There are also those who have expressed concern over EPA's 
risk assessment practices. I am one of them. I have long been 
concerned about the lack of transparency and participation 
inherent in EPA's risk assessment process, as well as how risk 
is communicated to the public. I was pleased with EPA's recent 
changes to the Integrated Risk Information System. These 
changes allow the public to be involved in the risk assessment 
process sooner. Now, environmental groups, scientists and the 
regulated community can provide data, research and comments on 
risk assessments before they are finalized. Additionally, there 
is now a concerted outreach effort to members of the scientific 
community and more rigorous peer review. I understand that 
there are those on this committee who believe this is somehow 
stifling EPA scientists or putting politics into the scientific 
process. But I don't understand how someone can stand up and 
say they support public right-to-know, scientific community 
participation and transparency when the Agency makes regulatory 
decisions but not support those very same principles when it 
comes to risk assessment. More science means better decisions; 
more defensible decisions.
    As I said 2 years ago during a toxics oversight hearing I 
held when I was Chairman, there is no shortage of strong 
feelings when it comes to chemicals and how they are regulated 
and managed. I look forward to hearing from our witnesses today 
and perhaps we will continue to uncover implementation problems 
that this committee, exercising its oversight, can encourage 
the Agency to rectify.

    Senator Boxer. Thank you.
    I am going to just use the privilege of the Chair just to 
respond to say that I don't mind your attacking me on this. We 
certainly did tell your staff that IRIS was a very important 
part. The reason, we really wanted Administrator Johnson here, 
because we think the buck stops there. But we also believe that 
TSCA and the role of TSCA is very important, even though the 
law has been weakened. This is bigger than just the IRIS 
program. It really is about all of our laws that rely upon risk 
assessment. But I don't mind that you are unhappy with me. This 
is certainly not going to be the last time.
    Senator Inhofe. Oh, I am not unhappy with you, if you would 
me respond.
    Senator Boxer. It is not the first and it won't be the 
last. But I just want to say this. For me, the most important 
thing, and I am sure it is for you, is not getting into an 
argument about the date of the GAO report and all that. We 
obviously wanted to understand it, read it and do the rest. But 
it was the report we had asked for.
    But what is important is the bottom line here, which is 
that we are being told, and this is a scandal, frankly, that 
our families are being put at risk because politics has entered 
the process of these risk assessments. And this is too 
important for us to bicker over how many days we told you this, 
that or the other.
    But I am happy to hold another hearing on this, and you 
would have every right to call whomever you want, and I would 
be delighted to do that at any time. But I really do want to 
thank you for being here, I know you have a hectic schedule.
    Senator Inhofe. Let me clarify, I certainly did not attack 
you, nor would I attack you, nor will I. But on this, I think 
if we do ask for am embargo, which can be very appropriate if 
we share that with each other, it would be a better idea.
    Senator Boxer. Yes, as you say, it has been done before, 
and I will.
    All right. Senator Lautenberg.

          OPENING STATEMENT OF HON. FRANK LAUTENBERG, 
           U.S. SENATOR FROM THE STATE OF NEW JERSEY

    Senator Lautenberg. Thank you, Madam Chairman. How nice it 
is to start off this spring day with a discussion of not the 
issues but the format or the process. And I think that if one 
attempts to hide information, the biggest obfuscation took 
place when we said that global warming is a hoax. And that 
tried to hide the effects and the seriousness of what that 
condition was ultimately is now, in front of our eyes, almost 
daily on TV and news, news delivery systems.
    So this is the kettle and the pot being called black. And 
Madam Chairman, I know you don't need it, but stay strong on 
these things. Don't let yourself be cowed.
    Senator Boxer. I make you that commitment.
    [Laughter.]
    Senator Lautenberg. Earlier this month we held a hearing on 
a matter that is still on many Americans' minds, the impact of 
contaminants in our Nation's water supply and the health 
hazards that they may pose to our residents. These contaminants 
include chemicals that are used in rocket fuel, gasoline 
additives proven to have negative effects on people's health. 
The real problem with our water supply is the lack of 
regulation by EPA. When it comes to regulating the industrial 
chemicals that are used in thousands of everyday products, from 
plastics to children's toys, the EPA is missing in action. The 
absence of EPA regulation is putting people at risk.
    For instance, scientific studies show a potential link 
between a chemical called Bisphenol-A, which is used to make 
baby bottles and water bottles and a host of medical problems, 
including cancer and reproductive issues arise. But here is the 
worst part. While the chemical is being developed and then used 
in the products we rely on, the EPA did nothing. Instead of 
speaking out for our health, they were silent. And the agency 
was not just silent about this single chemical. Out of the 
80,000 chemicals used now to produce the products they have 
found throughout our homes, the EPA has only tested 200. It is 
unacceptable.
    I refuse to let my grandchildren become the newer version 
of the canary in the coal mine when it comes to determining 
which chemicals are safe and which are not. We need to change 
the system so instead of passively waiting for a chemical to 
hurt somebody, we prove that it is safe before it gets into the 
hands of the consumer.
    That is why I will soon introduce an updated version of the 
Kids Safe Chemical Act. Chairman Boxer supported this critical 
bill when we introduced it during the last Congress, and I hope 
we are going to be able to work together on it again this year. 
This legislation would direct the EPA to make sure that every 
chemical in every product is safe before it winds up in the 
hands of the consumer.
    We already regulate pesticides and pharmaceuticals this 
way. It seems to me just common sense that we do the same thing 
for industrial chemicals that are used in everyday consumer 
products. I believe that it is, and I believe that the American 
public will agree. I look forward to working common sense back 
into our environmental laws to make sure the products we rely 
on every day are safe.
    Madam Chairman, as we approach the spring and we think 
about when it was that Rachel Carson started the anti-pollution 
movement, it was 1963, and it was the book called Silent 
Spring. It produced an anxiety, produced a tension to what we 
were doing to ourselves, particularly at that time with DDT. It 
took 9 years for that material to be obliterated from use and 
its presence.
    So this is the place and this is the time, Madam Chairman, 
that we have to get on with these things, stop talking about 
them and do something about them. Thank you very much.
    Senator Boxer. Thank you very much. And Senator, I would be 
very honored to be the lead co-sponsor on your legislation, 
because I think it gets to the heart of the matter.
    Senator Barrasso.

           OPENING STATEMENT OF HON. JOHN BARRASSO, 
             U.S. SENATOR FROM THE STATE OF WYOMING

    Senator Barrasso. Thank you very much, Madam Chairman.
    Madam Chairman, we do need to protect our children, no 
matter what age, from the effects of harmful chemicals. I doubt 
there is anyone in this entire room today who wouldn't support 
that goal. There is nothing we wouldn't provide for our 
children. Children need safe drinking water, life-saving 
medicines and safe food to eat.
    One question we might ask ourselves in this hearing is the 
following: has the chemistry industry and the EPA, under the 
Toxic Substance Control Act, helped improve the lives and the 
health of our children? To answer that, I would like to 
highlight an article that ran on Thursday in the Washington 
Post, a front page article, and the story is entitled For 
Children, a Better Beginning: Study Finds Progress on an Array 
of Issues from Birth to Age Ten.
    In brief, the article says, in a wide-ranging look at how 
children have fared in their first decade of life, there is a 
promising picture of American childhood. Sixth graders feel 
safer at school. Reading and math scores are up for 9 year 
olds. More preschoolers are vaccinated. Fewer are poisoned by 
lead.
    The analysis, which created a composite index of more than 
25 key national indicators, reports an almost 10 percent boost 
in children's well-being from 1994 through 2006. It goes on to 
say that, for example, the mortality rates for children ages 
one to four has declined by a third. With lead, the study 
reported a striking decline in the percentage of children 
younger than six who have elevated lead levels in their blood. 
The article mentions possible reasons for this trend, that is 
improved health and conditions, better Medicare care, better 
nutrition, mandatory use of seat belts, safer playground 
equipment.
    What role has the chemical industry played in providing 
better medical care, car seats and safer playground equipment 
and so on? I think there is a role. Chemistry, using chlorine, 
plays a role in producing 93 percent of the top-selling 
medications in the United States. Children benefit from some of 
these drugs, including those that treat epilepsy, asthma and 
depression. The antibiotic Vancomycin, with which I am very 
familiar, which is made with chlorine chemistry, has saved the 
lives of patients suffering from serious, stubborn bacterial 
infections.
    Chemicals make prosthetic devices used as polyvinyl 
chloride, or PVC, which is a common chlorine-containing plastic 
used to construct prosthetic legs and arms for children who 
lose their limbs or have birth defects. Thanks to these 
devices, many of these children can lead normal lives and 
participate in most activities.
    PVC is used to make blood bags, IV fluid bags and tubing to 
deliver needed care to young patients. Incubators for 
prematurely born infants are constructed of these same 
plastics. The chemical industry also makes the plastics used to 
manufacture child car seats, safer playground equipment.
    That is not to say that it is a completely rosy scenario 
for today's children. There are still areas of concern, such as 
increased rates of childhood obesity and also low birthweight 
babies. So we must be ever-vigilant. We need a strong and 
viable regulatory framework, the same framework under TSCA that 
has spurred advancements to help our children, not gotten in 
the way of it. This framework can provide the next series of 
advancements that can make the future better for all Americans.
    We must not enact policies that hamstring new chemical 
development that would prevent these new advancements. 
Otherwise that next child vaccine, the next bike helmet, the 
next prosthetic leg, will not be there if our families need it 
the most.
    TSCA has helped establish EPA as a leader around the globe 
in developing the tools we need to understand chemicals. It is 
a flexible statute that allows the EPA the ability to vary its 
assessments of new chemicals, according to the attributes and 
the expected uses of each substance. The framework ensures that 
the majority of new chemical substances pose little to no risk 
to our health or to the environment. Every chemical at a 
certain exposure is toxic. Fluoride used in toothpaste and 
purposely put into our drinking water, if ingested in massive 
amounts, can cause harmful health effects. As they say, the 
dose makes the poison.
    My point is that we don't need to scare folks about risks 
that are not there or of a low probability. That is why we need 
a statute that realizes the differences between risk of 
exposure and toxicity. Is TSCA perfect? No. Could there be room 
for improvement? Perhaps. Could the implementation of the 
current Act be improved? Absolutely.
    GAO released a report in 1997 that made recommendations for 
improvements. Many of these need to be implemented, in 
particular, recommendations for improving the use of 
confidential business information, prioritization of chemicals 
for risk evaluation, reducing some of TSCA's administrative 
burdens relating to chemical testing requirements and improving 
and validating the models EPA uses to assess and predict the 
hazards of chemicals.
    With that, Madam Chairman, I welcome the witnesses and look 
forward to the testimony. Thank you, Madam Chairman.
    Senator Boxer. Thank you.
    I just would like to put in the record, without objection, 
a list of toxic chemicals that have been regulated under the 
IRIS program. That is why our kids, that is certainly a strong 
reason why we are seeing some good news on our kids. But what 
the White House is trying to do is change it, is bring politics 
into it. So we had, for example, under IRIS, we have had 
regulations about arsenic, mercury, cyanide, toluene, 
chlordane, DDT, PCBs, it goes on and on, many chemicals with 
very long names.
    The bottom line is, the purpose of this hearing is, we 
don't want to go backward. Some of us want to make it even 
stronger, not to hamstring our companies from making 
prosthetics, I don't know where that comes into it, to be 
honest with you. We are talking about protective standards in 
our water, in our air, not in prosthetics. So let's not raise 
false issues.
    So let me just be clear about what today is about. What we 
have learned is that this program that has in fact made our 
kids safer is in jeopardy. As a matter of fact, the 
Administration claims under their new way of doing things, 
which they are now institutionalizing or trying to, that they 
would take care of 50 chemicals? Fifty in 1 year?
    Male Speaker.
    [Remarks off microphone.]
    Fifty. And they did two. So that is the purpose of this 
hearing.
    [The referenced material was not received at the time of 
print.]
    Senator Barrasso. Madam Chairman, not to be argumentative--
--
    Senator Boxer. You can be.
    Senator Barrasso. Pardon me. The plastics that I have seen 
as an orthopedic surgeon for 25 years that have been used to 
build the prosthetics are advances in plastics, and they are 
chemically related. That was my point.
    Senator Boxer. You are right. But we are talking about 
regulating these chemicals in water and air. We are not talking 
about regulating them for prosthetics. We are not talking about 
banning them. We are talking about regulating them, so that 
kids don't breathe them, drink them, play in them on Superfund 
sites and the like.
    So we are talking past each other. Nothing that you said do 
I object to. I am not suggesting that these be banned for 
prosthetics or anything else. I am saying we need to control 
these when scientists tell us they are going to cause birth 
defects, they are going to cause cancer. That is what we are 
talking about.
    Senator Whitehouse.

         OPENING STATEMENT OF HON. SHELDON WHITEHOUSE, 
          U.S. SENATOR FROM THE STATE OF RHODE ISLAND

    Senator Whitehouse. Thank you, Madam Chair.
    I just want to express my appreciation to you for holding 
this hearing. I think it is an important hearing. We have north 
of 80,000 chemicals to which American families are exposed, 
very few of them are tested for safety. In the program that 
currently exists the burden of proof is on the regulators to 
show that they are unsafe, which makes the balance really in 
favor of industry rather than in favor of families.
    There is increasing awareness of health risks that these 
chemicals can cause. Unfortunately, we are also operating in an 
environment in which the Bush administration record on 
environmental and public health issues gives very much the 
impression of being not a part of the progress that Senator 
Barrasso described, but a counter-weight to the progress that 
Senator Barrasso described.
    EPA itself has too often been in the way of public 
protection, as we have seen, with particularly the CAFE 
standards and waiver. That is the most prominent. But over and 
over again there are cases, and on the occasions when the EPA 
does stand up for American families who face these health 
risks, then the Administration has put OMB in the role of being 
sort of the Administration hit man to knock those down.
    So I think there is a legitimate concern that the 
procedures that the Government Accountability Office has 
addressed in its report may stack the deck further against 
American families who don't have the expertise to make this 
kind of determination and are relying on the Government to help 
provide them with a safe environment.
    So I think it is a great hearing, I am glad that you have 
called it and I look forward to hearing from the witnesses.
    Senator Boxer. Thank you, Senator, and I appreciate your 
leadership on oversight of EPA in general. You have been very 
strong on that, so we thank you very much.
    Senator Craig.

            OPENING STATEMENT OF HON. LARRY CRAIG, 
              U.S. SENATOR FROM THE STATE OF IDAHO

    Senator Craig. Thank you, Madam Chair.
    Well, I am sitting here listening trying to determine 
whether this is a TSCA hearing or an IRIS hearing, but I will 
assume that it is the politics of chemicals. Probably that is a 
broader premise to the issue at hand. If you are going to talk 
about the politics of chemicals, and that is legitimate, you 
also have to talk about the importance of chemicals in our 
society today and what they have done for society, along with 
what they have done to damage society in one form or another. 
Those are all phenomenally legitimate criteria for an oversight 
hearing.
    And Madam Chair, I am sorry, I am going to err on the side 
of a doctor today and not a politician. I am going to err on 
the side of Dr. Barrasso and his statement because I think it 
was overreaching in the broad sense, not overreaching, but it 
reaches out in the broad sense to talk about striking balance 
and assuring quality human health in our Country.
    Our history is replete with the lack of knowledge and 
understanding as to the application of or the pollution of 
chemicals into our environment. And when we found it out, when 
we knew it, we began to move. From the very loud cry of Silent 
Spring, as one Senator mentioned, to what we have done 
effectively with TSCA, which is today a responsible model of 
public policy that works and brings about that kind of balance.
    My great fear is not unlike what we are experiencing today 
in the petrochemical industry. When we didn't do it they did 
it, meaning somebody outside our Country. And now we are being 
victimized because we weren't smart enough to continue 
production in our Country and do it in a clean and responsible 
and environmentally sensible way.
    How many times this year has our society been warned about 
a product coming in from outside our Country that might in some 
way injure human health? The more we regulate in ways that are 
punitive, that deny a reasonable entry into the market based on 
sound science, the more someone else is going to do it 
offshore. The beauty of what our Country has always done 
historically is its phenomenal transparency, not just for us 
and our consumer when the knowledge base was there to do so, 
and a good regulatory process produces that knowledge base, but 
at the same time it was transparent to the rest of the world.
    TSCA's importance is directly tied to entry into 
manufacturing, processing, importing, and the use and 
distribution in commerce as it relates to how we regulate 
chemicals. Let us also recognize the value of the industry 
itself to the economy of our Country. It just so happens that 
it is about a $635 billion industry. We represent 22 percent of 
the world's economy as it relates to the chemical industry. And 
we are rapidly shoving it offshore by cost of input and cost of 
regulation. That shouldn't happen. We ought to continue to lead 
in that area, and we are not talking about just minor jobs, we 
are talking about jobs in the industry that average $50,000 and 
above, a very important industry to our Country.
    So fair and balanced oversight, absolutely, Madam Chairman. 
Political forum, shouldn't necessarily be that, although I am 
not so surprised that it has become that. Our job is oversight 
to see whether TSCA is working, whether IRIS is working. If it 
isn't, then we ought to make it work. More importantly, we 
ought to make it work in concert with what the rest of the 
world is doing to make sure we do it better, more cost-
effective, at the same time with a sensitivity to human health 
that is paramount.
    It is kind of like where we are today, Madam Chair, with 
energy. If it isn't clean and if it is an emitting source, we 
don't want it any more. We are driving our energy economy into 
cleanliness. We ought to do the same thing with the 
petrochemical industry. And that isn't run them offshore, 
invite them to stay in a criteria of public policy that allows 
them to prosper and provide safe products for the consumer. 
That is our job. We can make it as political as we want to or 
we can be reasonable and responsible. I would guess the public 
in the large would want us to be the latter instead of the 
former.
    I thank you and look forward to the testimony.
    Senator Boxer. Thank you. I feel compelled to respond, 
since my name was invoked, Madam Chairman, several times.
    No. 1, it is not our job to keep the chemical companies at 
the table. It might be in another committee. This is the 
Environment and Public Works Committee. The EPA has a job to 
protect public health. When it comes to the profitability of 
the chemical companies, let's take that up in the Commerce 
Committee. Let's look at that. Yes, but not as a criteria here. 
Our job is very straightforward, and that is protect our people 
from harm, from chemicals, toxics. And if we hadn't been doing 
it, all those statistics that Dr. Barrasso, if I might say, has 
cited, wouldn't be there.
    Now, you have taken your stand with Dr. Barrasso. Now, he 
is an orthopedic surgeon and I am really honored to have him on 
this Committee. On the panel today, we will have a pediatrician 
and we will have an Ob-Gyn. In EPA, we have many scientists 
whose job it is to protect the public. So while we all need to 
be listened to, I have other credentials. I am a grandma, I 
bring those proudly to the table.
    But the fact of the matter is, the people who know about 
this are the people who are experts in toxic, are the people 
who see pregnant women, who are warning them about the toxic 
chemicals that are unfortunately ever-present.
    I also want to make one last point here, which I think is 
important. There seems to be all this ``confusion'' about this 
hearing. Let me tell you the title of this hearing today, no 
confusion, ``Oversight on EPA Toxic Chemical Policies.'' 
Policies. That means anything and everything is on the table. 
We can look at IRIS, we can look at TSCA.
    But politics shouldn't be played when it comes to 
protecting the health of our families. That is one of the 
reasons we have this hearing today, because politics is being 
played when you have the White House suddenly turning its back 
on the science and the EPA and inviting to the table, through 
various agencies, the special interests. That is not what 
should be happening when it comes to protecting the health of 
the people.
    And I am a little stunned that my colleagues on the other 
side of the aisle aren't working with us on this, because you 
love your kids and grandkids as much as I love mine, and you 
would throw yourself in front of a truck for them. Well, we may 
have to throw ourselves in front of a train for them here, 
because there is a train leaving the station with Administrator 
Johnson on it and President Bush's OMB on it, trying to derail 
a very important risk assessment program that has at least done 
something good to keep our children safe. If this is going to 
go forward unchallenged, we are going to see a slowdown and a 
delay. And everyone says that, including the GAO. We are 
harming our children.
    Senator Barrasso. Madam Chairman, since my name came up----
    Senator Boxer. Well, we are not going to start that, but I 
will go back to you after we, for the first round of questions.
    Senator Klobuchar.
    Senator Klobuchar. Thank you very much, Chairman Boxer. 
Thank you for holding this hearing.
    Just listening to Senator Craig, I just view our role as 
one of oversight, that is correct. But it is also oversight of 
enforcement. I come at this not only as a mother who, when you 
think first hand of these baby bottles and things like that 
could have toxic chemicals in it, it just hits you hard, but 
also as a prosecutor. I have always learned you can have strong 
laws and politicians can stand up and make credits about laws. 
But if you don't have the enforcement angle and you don't have 
people watching over to make sure that these laws are being 
enforced, then we are not doing our job and Congress has to 
come in. I believe that is what we are trying to do, is to 
figure out what is going on here.
    I come at this not naively but as someone that looks at 
this, look what happened with these toys. Who would have ever 
thought, and I don't think anyone would believe that people 
want to allow AquaDots to morph into date rape drugs in this 
Country, and that is what happened here. That is what happened. 
They weren't, our Country, our Consumer Products Safety 
Commission, wasn't watching over these toys and they came into 
our Country, and they shouldn't have. And this happened again 
and again and again, and finally Congress had to step in, when 
the Administration did not, and say, we need more tools, what 
do you need to enforce these laws, we will help you. What do 
you need? A better statute on the book? We will help you. And 
that is what happened in the last year in this Congress.
    So it doesn't surprise me at all that we might have to get 
involved in these toxic chemicals. And I was shocked to read in 
this hearing the testimony of Ms. Annette Gellert, who is going 
to be testifying on the second panel, and I am not going to be 
able to be there for that, because have a Commerce hearing on 
the mortgage crisis going on at the same time. But I read about 
how she had blood tests done on herself and her daughter, and 
out of 70 toxic chemicals they tested for, they found 36 in the 
mother and 34 in the daughter. You figure as a mother that you 
are supposed to be able to provide your child with a safe 
environment and you do your best, and then you find that things 
outside of your control are coming into your home.
    I figure that in a Country with as many resources as ours, 
there is no reason that people should have to get their safety 
information from news stories or from people that are already 
sick in the hospital. That holds true not just for the EPA, but 
across all Government agencies, whether we are talking about 
the spinach weed, the pet food that we get or the drain at the 
community pool. These are all things that have gone on in this 
Country in the past year.
    So I am looking forward to hearing from our witnesses, Mr. 
Stephenson from the GAO, about how the Toxic Substance Control 
Act is being controlled, where the weaknesses have been and 
what we can do better to give Americans the sense of safety 
that they deserve. Thank you very much.
    Senator Boxer. Thank you, Senator.
    So we will start our panel first with James Gulliford, 
Assistant Administrator, Office of Prevention, Pesticides, and 
Toxic Substances, to be followed by Mr. John Stephenson, 
Director, Natural Resources and Environment, from the General 
Accounting Office, who did this report.
    Mr. Gulliford.

STATEMENT OF THE HON. JAMES GULLIFORD, ASSISTANT ADMINISTRATOR 
     FOR PREVENTION, PESTICIDES AND TOXIC SUBSTANCES, U.S. 
                ENVIRONMENTAL PROTECTION AGENCY

    Mr. Gulliford. Good morning. I appreciate the opportunity 
to share with the Committee our progress to date as well as new 
efforts underway to protect human health and the environment 
from the adverse effects of chemicals as authorized under the 
Toxic Substances Control Act. TSCA provides EPA with the 
authority to review and manage risks from new chemicals and to 
collect health and safety data as well as production, use, and 
exposure information on industrial chemicals.
    We use sophisticated models to assess chemicals, we 
facilitate pollution prevention and we implement voluntary 
programs to support our regulatory framework. We work closely 
with the domestic and international community. As an example, 
we have collected health and safety data on 2,200 high 
production volume chemicals which cover more than 93 percent of 
the organic chemical production volume. EPA has also 
successfully used TSCA to bring about the phase-out or 
significantly reduce the production, use or release of various 
chemicals, including PFOS, PFOA and other priority chemicals. 
There are many more accomplishments detailed further in the 
written testimony I have submitted.
    Overall, while no law is perfect, TSCA provides broad 
authority for the agency to adequately control new and existing 
chemicals and to address emerging chemical issues as they 
arise. As I said, while there are real accomplishments, we know 
there is more to be done. So this past August, the countries of 
North America came together to accelerate and strengthen the 
management of chemicals in North America. This new effort we 
now refer to as ChAMP, the Chemical Assessment and Management 
Program.
    We believe these efforts will significantly improve what we 
know about industrial chemicals, and will allow the Agency to 
pursue necessary protective actions or mitigation if needed. We 
have committed, by 2012, to complete initial assessments and 
initiate needed actions on over 6,700 high production and 
moderate production volume chemicals. This builds on the work 
that EPA has done under the HPV challenge program, to obtain 
and assess screening level hazard and environmental fate 
information and use this new information reported under the 
TSCA inventory update regulations.
    To meet these commitments, EPA is developing risk-based 
prioritizations for HPV chemicals based on hazard, exposure and 
risk screening characterizations. For the moderate production 
volume chemicals, we will rely on available data, Canada's work 
on chemical categorization and EPA's expertise in structural 
relationship analysis to prepare initial assessments. There is 
a down payment on these commitments. We have already posted 
hazard characterizations on 238 chemicals and in March, posted 
an initial set of risk-based prioritizations for 19 chemicals. 
These characterizations, which we make available on our 
website, provide important scientific information and analysis 
on hazards, exposure and risks, and position us to take any 
needed follow up actions. The 2012 commitment for completing 
the North American assessment work also sets up opportunities 
for cooperation with the European Union, given the timing of 
the REACH registration schedule, which extends from 2010 
through 2018.
    To foster cooperation, we have regular consultations with 
officials from the European Commission and OECD countries. It 
is vitally important to invest in this cooperation, to leverage 
work, avoid duplication and improve the protection of public 
health and the environment, both at home and abroad.
    While we support the health and environmental goals of 
REACH, we believe that effective protection can be obtained 
through a more targeted and strategic approach to chemical 
assessment and management under our ChAMP efforts. In addition 
to the above commitments, where work is already underway, we 
are asking for feedback on potential enhancements to the ChAMP 
program, which combined with our 2012 commitments would provide 
the most comprehensive approach to dealing with chemicals that 
has ever been developed by the Environmental Protection Agency.
    The first enhancement involves developing a program similar 
to the HPV challenge, but for inorganic HPV chemicals. The 
second enhancement under consideration would reset the TSCA 
inventory to better reflect the chemicals actually made, 
imported and used in the U.S. We have begun an extensive effort 
to invite input from a wide range of stakeholders.
    I would like the Committee to know that the IRIS process 
that has been discussed today and the revisions to the process 
are managed by Dr. George Gray, the Assistant Administrator of 
EPA's Office of Research and Development. It is my 
understanding that ORD senior staff have already briefed the 
Committee on this effort.
    Of course, the TSCA program does utilize the IRIS data base 
as a resource for reviewing chemicals, like our efforts under 
ChAMP. We work directly with ORD on a handful of assessments 
that are of particular relevance to us, like PFOS and PFOA. 
Again, while the IRIS data base provides my office with useful 
input, ORD is the lead for the overall process, and they would 
be best able to respond to questions on the recently announced 
process revisions.
    I am pleased to be here to share with you the highlights of 
our chemicals work. We remain appreciative of the ongoing 
interest of this Committee in TSCA and our new efforts under 
ChAMP. I believe that TSCA provides EPA with the statutory 
tools necessary to protect public health and the environment, 
and the agency looks forward to continuing to work closely with 
members of this Committee, your staff and others from GAO.
    Thank you.
    [The prepared statement of Mr. Gulliford follows:]



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Senator Boxer. Mr. Stephenson, thank you.

 STATEMENT OF JOHN B. STEPHENSON, DIRECTOR, NATURAL RESOURCES 
     AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Stephenson. Thank you, Madam Chairman, members of the 
Committee.
    GAO has issued several reports on EPA's implementation of 
TSCA and EPA's voluntary programs to control dangerous 
chemicals. We have concluded in this work that TSCA is 
outdated, cumbersome and difficult to use in controlling the 
more than 80,000 chemicals currently in the inventory.
    Since TSCA was enacted in 1976, EPA has used its authority 
to require chemical industry testing for fewer than 200 
chemicals, that is in 30 years, and has issued regulations to 
limit or ban the production of only 5 chemicals or groups of 
chemicals in that same time. Voluntary programs provide EPA 
useful information, but they don't negate the need to overhaul 
TSCA.
    In comparing the U.S. approach for controlling dangerous 
chemicals under TSCA to the European Union approach under the 
REACH program, we note that TSCA places the burden of proof on 
EPA to demonstrate that the chemical poses a risk to human 
health before it can regulate its production or use, whereas in 
Europe, REACH generally places the burden of proof on the 
chemical industry to ensure that chemicals do not pose such 
risks or that measures will be taken for handling chemicals 
safely.
    My written statement includes additional information from 
the toxic chemical control reports we have issued over the past 
couple of years, but I want to focus my comments today on our 
new report concerning EPA's Integrated Risk Information System, 
or IRIS, a data base that contains EPA's scientific position on 
potential health effects of exposure to more than 540 toxic 
chemicals. IRIS is a critical component of EPA's capacity to 
support scientifically sound environmental decisions, policies 
and regulations.
    In summary, we found that the IRIS data base is at serious 
risk of becoming obsolete, because the EPA has not been able to 
routinely complete timely, credible assessments or decrease its 
backlog of 70 ongoing assessments. Our report recognizes steps 
EPA has taken to improve IRIS since 2000, such as increasing 
funding and centralizing staff, but points out that these 
efforts have been thwarted by new OMB-required interagency 
reviews, the growing complexity and scope of chemical 
assessments, EPA decisions to delay assessments to wait for new 
research or additional uncertainty analysis on a given chemical 
and the compounding effects of delays.
    While EPA has prepared over 32 toxic chemical assessments 
for external review in the past two fiscal years, only four 
have been finalized. Comments by the National Academies on 
EPA's assessment of trichloroethlyene or TCE highlight the 
problem. In 1998, EPA initiated a risk assessment of TCE, a 
degreasing agent used widely by the Department of Defense and 
others. EPA's Science Advisory Board approved the draft risk 
assessment for public comment in 2001. DOD and others raised 
questions about the assessment, which led to a National 
Academies review. The Academies specifically noted in its 2006 
report that the risks of TCE were substantial and that 
additional studies were not necessary to finalize an assessment 
needed to protect public health.
    Nonetheless, after more than 10 years, TCE is back at the 
draft development stage. To get EPA moving, Senators Clinton, 
Boxer, Lautenberg, Kerry and Dole, spurred by TCE contamination 
in drinking water at Camp LeJeune, introduced a bill last 
August that would require EPA to complete its risk assessment 
and issue a drinking water standard in 18 months.
    Our report contains eight specific recommendations to EPA 
for streamlining the IRIS program, improving the transparency 
and credibility of its assessments and ensuring that EPA has 
the requisite independence to achieve these goals. EPA agreed 
to consider our recommendations in its February comments on our 
draft report. EPA released its revised IRIS assessments process 
after the report on April 10th.
    It is an understatement to say that we are disappointed in 
EPA's response. The revised IRIS process is not improved and is 
in many respects worse than the draft we reviewed. For example, 
transparency is a cornerstone of sound science. And the draft 
IRIS process we reviewed would have made comments from other 
Federal agencies part of the public record.
    However, EPA's new process expressly defines such comments 
as deliberative, excluding them from the public record. This 
new process will exacerbate the problems we identified in our 
report and sought to address with our recommendations, all of 
which were aimed at preserving the viability of this critical 
data base, which is integral to the EPA's mission of protecting 
the public and the environment from exposure to toxic 
chemicals.
    In light of the importance of the IRIS program, we believe 
that Congress should consider directing EPA to suspend 
implementation of its new IRIS process and develop one that is 
responsive to our recommendations for a streamlined, fully, not 
selectively transparent process aimed at improving the 
timeliness and credibility of IRIS assessments. EPA should also 
seek congressional and public input before finalizing IRIS.
    Madam Chairman, that concludes the summary of my statement.
    [The prepared statement of Mr. Stephenson follows:]



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Senator Boxer. Thank you very much.
    We will do 5-minute rounds and probably have two rounds.
    Mr. Gulliford, what chemicals have you banned or regulated 
under TSCA that were not voluntary withdrawn or regulated by 
the industry or by Congress since you took over?
    Mr. Gulliford. Thank you, Madam Chair.
    We regulate and take regulatory actions related to 
chemicals almost daily. Every year, we receive about 1,200----
    Senator Boxer. No, no, no, I----
    Mr. Gulliford [continuing].--for new chemicals----
    Senator Boxer. I am not asking you that. How many have you, 
in your position, chemicals have you either regulated or banned 
without them being withdrawn or regulated by the industry 
itself or banned or regulated by Congress? Do you have that 
number off the top of your head?
    Mr. Gulliford. The actions that we take, our actions at 
EPA, do reflect our work, which in effect has the impact of 
determining whether chemicals are brought into production or 
not.
    Senator Boxer. I know, but I'm asking you----
    Mr. Gulliford. Those are regulatory actions.
    Senator Boxer [continuing].--for a specific answer. And so 
you don't have it. So will you please send to me in writing the 
lists and names of chemicals that under TSCA, since you took 
over, have been either banned or been regulated other than 
those that the industry itself decided to do or Congress took 
into its own hands, which we have done. So if you could do 
that, I would be really appreciative. I understand the process. 
I am trying to get to what have you done in your position.
    [The referenced material follows:]
    Senator Boxer. Now, Mr. Stephenson, the GAO report states 
``The farther removed the scientists and experts who have 
prepared or peer-reviewed the assessments are from the 
negotiations and decisions over assessment changes requested by 
OMB and other Federal agencies, the decisions are based more on 
political rather than scientific considerations.'' I think that 
is important, because Senator Craig kind of accused this 
Committee of playing politics. The whole point is, the GAO 
report says that there is political considerations.
    So how important is it to ensure that IRIS assessments are 
based on solid science rather than political considerations?
    Mr. Stephenson. According to the National Academies, there 
are two components there is a risk assessment part and there is 
the risk management part. The management part is where you 
consider political input or other circumstances, you do cost 
benefit analysis and decide regulatory approaches.
    However, in the risk assessment process, you don't want----
    Senator Boxer. That is what I am talking about.
    Mr. Stephenson [continuing].--anybody but scientists 
involved.
    Senator Boxer. Right. That is the point.
    Mr. Stephenson. That is our major problem with the lack of 
transparency and the new process is that any comments that EPA 
receives from either the Department of Defense, NASA or OMB 
itself are withheld from the public.
    Senator Boxer. That is the second question. But the first 
point I want to reiterate that you made, I think it is critical 
here, is that in the risk assessment part of this, it should be 
pure. It should be about the health of people, is that right?
    Mr. Stephenson. Absolutely.
    Senator Boxer. Absolutely. OK, that is No. 1.
    Now, second, the secrecy which you raised. My understanding 
is, in your report you say that the comments made by these 
other entities are kept secret by the White House. You find a 
problem with that, I certainly find a problem with that. Why do 
you think this is the case? Do you have any thoughts?
    Mr. Stephenson. I think that the OMB is muddling the two 
parts of the process. They are getting involved in the science 
portion, the early assessment of chemicals, when they should be 
getting involved in the later, what should the regulatory 
approach be, what is the least burdensome approach we can do to 
regulate this chemical. They should not be muddling in the 
front part, in the science.
    Senator Boxer. OK. Mr. Gulliford, doesn't EPA's Office of 
Prevention, Pesticides and Toxic Substances rely on information 
from IRIS in their work to help prevent, to help protect public 
health?
    Mr. Gulliford. With respect to our chemicals program, yes. 
There are a number of the IRIS characterizations that are 
important to us. Through our ChAMP work, we are looking at 
doing well over 7,000 chemical assessments.
    Senator Boxer. But I am just trying to get at the point 
about IRIS here. So you do, in some cases rely on IRIS?
    Mr. Gulliford. We have asked that certain chemicals be 
studied under IRIS and taken through the IRIS process.
    Senator Boxer. Good. That is an important point. So don't 
you want to ensure that your office uses the best available 
science to protect public health and not secret information 
that is tainted by outside interests?
    Mr. Gulliford. We do that every day. We utilize the best 
science that is available----
    Senator Boxer. Well, you count on IRIS, you count on the 
IRIS program for certain of these, and we have been told by the 
GAO, not by me or anybody else, that politics is in the 
process. So when you now hear, you get your information ipso 
facto, if GAO is right, and I tend to believe them, they have a 
reputation for integrity and they have no axe to grind here, 
you are getting tainted information. And that is a problem.
    Senator Barrasso.
    Senator Barrasso. Thank you very much, Madam Chairman.
    Early you mentioned about my background and training as an 
orthopedic surgeon. The derivative of orthopedics comes from 
the Greek, and it is the word ortho, meaning straight, and 
paedos, meaning child. So lots of the training I do is with 
children and I have very significant concerns in those areas.
    Mr. Gulliford, if I could, I mentioned earlier this 
Washington Post story about all the advances in children and 
kind of getting the lead out of the system. Isn't that 
something EPA should take credit for?
    Mr. Gulliford. EPA has worked with HUD and with other 
agencies for many years on issues of lead. We are very pleased 
that, for example, or the last 20 or so years ago, we have gone 
from as many as 3 million children affected by elevated blood 
levels to now where CDC estimates roughly 300,000. We are also 
very pleased with our new lead rule, which we believe will 
actively help again to prevent exposures to lead.
    Senator Barrasso. When you look at exposures in terms of 
assessing risk to humans, don't you really assume the worst 
case scenarios in terms of an exposure and try to stay below 
those numbers?
    Mr. Gulliford. We look for realistic exposure estimates. We 
build in safeguards to assure that we don't approach those 
exposure thresholds that we believe are dangerous or 
threatening.
    Senator Barrasso. If we take a look at this one size fits 
all approach to so many things I see happening in Washington 
here, if you used that approach to every chemical under TSCA, 
wouldn't you end up wasting a lot of your time on some low 
priority chemicals and really deflecting from the real issues 
affecting our children?
    Mr. Gulliford. We absolutely would be. One of the things 
that I believe is most important is that we find a way to 
prioritize our work, to identify those chemicals of concern 
with respect to health of children, adults, all our people and 
the environment. That is why in our ChAMP program, we have 
developed a prioritization process to identify those chemicals 
and then follow up with industry to assure that exposure of 
those chemicals does not occur either to workers or the 
environment or to people that use products that are produced 
from the use of those chemicals.
    Senator Barrasso. So I take it then that you don't always 
agree with the chemical industry, or shall I say the chemical 
industry doesn't always agree with you?
    Mr. Gulliford. No, absolutely not. Our work is to evaluate 
the data that they give us and make independent decisions by 
the agency, rather than to allow industry alone to make 
decisions.
    Senator Barrasso. Thank you, Madam Chairman.
    Senator Boxer. Thanks. I just want to let the record show 
that the lead, the progress on lead was made under the old 
rules, which is what we are trying to defend here today. And 
that will show, because that is one of the good things that 
happened under the old way.
    Senator Whitehouse.
    Senator Whitehouse. Thank you, Madam Chair. I am not sure 
it is part of the record, so I would just like to start by 
showing Mr. Gulliford the picture of the IRIS process. I 
believe we got this from EPA staff. And I just want to make 
sure that this is correct.
    It shows, before 2004, an IRIS process that was already 
pretty----
    Senator Boxer. Would you bring that over to Senator 
Whitehouse and show it----
    Senator Whitehouse. And then, well, hold on a second.
    Senator Boxer. That is the new one. Where is the old one?
    We don't have it. So show that old one, and then we will 
show the new one.
    Senator Whitehouse. It starts already looking pretty 
complicated with 11 steps here. Then from 2004 to 2008, it 
started to look more like this, it went from 11 to 15 steps----
    Senator Boxer. That is the one.
    Senator Whitehouse [continuing].--and became every more 
complicated. And now the draft process looks like this and has 
all sorts of, I can't count the number of steps and sub-steps 
that it has. It just looks to the lay viewer as if this process 
is getting more complicated and cumbersome.
    In addition, I am concerned about the role that OMB plays 
being injected into the process relatively early on. What 
scientific expertise does the Office of Management and Budget 
bring to the table in these discussions about risks of 
chemicals?
    Mr. Gulliford. Let me start with your first question and 
your comment on the complexity. That board also can demonstrate 
the fact that an effort is being made to be more explicit about 
all of the steps and to further or better define them, as well 
as perhaps adding steps. So there are a couple of things in 
effect there.
    OMB has scientists and economists and professionals that 
work for them as well. Their role principally, though, is to 
assure effective interagency review. It happens with rules, it 
happens with other programs. And the agency does believe that 
in the IRIS process, interagency review, opportunity for 
interagency input into the process, as well as public input, 
public review and finally science review as well by third party 
outside scientists, all of those are important parts of the 
IRIS process.
    Senator Whitehouse. Should we have concern about the 
private nature, the non-public nature of OMB's review? As I 
understand if, it you are an American company who wants to 
comment on this, on a piece, on an administrative process, a 
chemical that is being put through the IRIS process, your 
comments have to be public. And if you are an American advocacy 
group, if you are the Heart Association or the Cancer Society 
and you want to comment on it, your comments have to be public. 
And if you are an American mom or citizen who wants to comment 
on it, your comments have to be public.
    The carve-out is for other Federal agencies. And what it 
seems to create is a loophole where, if you want to influence 
this process and you don't want to say it publicly, you go to a 
White House, you get them to tell OMB what to do, because it is 
part of the White House, and you can stick whatever comments 
you want in, and it is a way to launder comments you wouldn't 
make publicly through politics and into this. Isn't that a 
legitimate concern?
    Mr. Gulliford. That is an assumption that you are making. I 
am not certain that would or wouldn't happen. I don't believe 
that it would.
    Senator Whitehouse. Is there anything in the process that 
would prevent that from happening?
    Mr. Gulliford. There is the allowance for the agency to 
review mission-critical chemicals and that be a protected 
process.
    Senator Whitehouse. How does that keep OMB out, if OMB has 
been made amenable to political----
    Mr. Gulliford. You are making the assumption that OMB is 
made amenable to that political process, in the Office of 
Management and Budget for interagency review, as I had stated 
earlier.
    Senator Whitehouse. You know, one of the things we do in 
American Government is we have things be transparent and above-
board so we can prevent things from happening. So it is usually 
wise, when you see a system that create an avenue for that kind 
of politics to happen, to press on it and try to figure out why 
the system wouldn't protect itself against that. If you leave a 
door open to that, I don't think it is an adequate public 
protection to say, well, we can't prove that it is being used 
for that purpose is because the very process keeps it private 
and confidential and out of the public view, allows it to be 
done behind closed doors. That doesn't seem right, does it?
    Mr. Gulliford. The final products of the IRIS process are 
reviewed by third party science organizations. That is the 
purpose, that ultimately, when EPA has gone through the 
process, EPA has heard input from the public, EPA has heard 
input from agencies, EPA has heard, people have been given the 
opportunity under this process to bring data, bring 
information, to bring opinion to the process, ultimately it is 
still, at the end of the day, it is EPA's decision. EPA makes 
the determinations on those final IRIS characterizations. And 
then they are split out for third party review.
    So I believe it is a transparent process. It is a process 
that ultimately results in a science-based result.
    Senator Whitehouse. Madam Chair, my time has expired.
    Senator Boxer. Yes. I thank you, Senator. I just want to 
say, Mr. Gulliford, and you are a very good witness, but 
Senator Whitehouse is not the one making these charges. GAO 
said this thing is so secret they talked about a black box, 
that this information that you say is public is never public. 
It is actually in a black box, it is secret.
    So when you say to Senator Whitehouse that he is not 
correct, he is relying on the investigation of this process.
    Mr. Gulliford. I apologize. Senator Whitehouse asked the 
question, that is why----
    Senator Boxer. I understand, but I just want to make sure 
that we understand the GAO makes this point. It is not an 
individual Senator. He is just reiterating what we now know is 
the truth about the process.
    Senator Craig.
    Senator Craig. Thank you, Madam Chair.
    Gentlemen, thank you very much for your testimony. I am 
trying to understand the process, because it appears that it is 
the process that is under attack today and not the outcome. I 
think we are obviously concerned about transparency. We are 
also very concerned about outcome.
    Something that has not been mentioned, and I ask you, Mr. 
Gulliford, does it fit into the process, and that is, how many 
pre-manufacturing notices has the EPA received versus notices 
to commence? Now, the reason this is important, when we are 
talking about propriety and ownership of product and 
development of product, part of the value of the ownership is 
the chemistry and the formula.
    But it is important to understand that as it relates to 
human health and understanding. So the question then is, 
because it appears that in pure transparency you get nothing 
done, because someone else can steal your work product. At the 
same time, you want to make sure your work product, the end 
process, is safe for human consumption and association.
    So the question again is, how many pre-manufacturing 
notices has EPA received versus notices to commence, meaning to 
commence production once the process is completed? Could you 
respond to that?
    Mr. Gulliford. We get about 1,200 PMNs each year.
    Senator Craig. And a PMN is?
    Mr. Gulliford. Pre-manufacturing notice. I am sorry.
    Senator Craig. Thank you. Use common language for us, would 
you please.
    Mr. Gulliford. I appreciate that. Since TSCA, roughly 
47,000 of those PMNs. We have added 21,000 new chemicals to the 
chemical inventory, which means that during that process, 
during our regulation of those notices, our evaluation of those 
chemicals, our concerns for those chemistries, our interaction 
with those companies, because as you say, much of that is 
confidential business information. Those chemicals are either 
withdrawn because, by our work with them, they have come to the 
conclusion that they are not an appropriate chemical for us, or 
ultimately some of them do make it through the process, 
roughly, I think 21,000 since TSCA.
    Senator Craig. But percentage-wise, I understand it is 
around the 50 percent mark.
    Mr. Gulliford. Or less.
    Senator Craig. Or less. Those who are, that which is 
submitted for testing and oversight, or review, through the 
process, versus that which actually makes it to the market. And 
often they are withdrawn, are they not?
    Mr. Gulliford. That is correct.
    Senator Craig. For future research to meet the compliance 
standards that you say they must meet.
    Mr. Gulliford. That is correct.
    Senator Craig. I see. I guess my next question, because Mr. 
Stephenson says we ought to stand down and review, I think I 
understand you right, and reapproach IRIS differently, and in 
that, you have referenced REACH. REACH, of course, is what the 
European Union uses. So that is your observation.
    So let me ask a question, Mr. Gulliford, has EPA examined 
REACH and its thoroughness or its responsiveness? Because it is 
being touted here today as something that is working or is more 
transparent or is more inclusive, versus what you are doing. 
And first of all, let me ask you that. I understand there are 
about 30,000 chemicals that the EU will need to register. How 
do you think it compares? We have already heard from Mr. 
Stephenson about he thinks it compares.
    Mr. Gulliford. REACH is a regulatory chemical management 
scheme that is now in place in the EU. It is just now beginning 
to collect the information that is required, the testing, the 
data that will be developed by industry for their estimate 
again is roughly 30,000 chemicals. We will see how many are 
actually produced by them and submitted.
    So at this point in time, they are still in the data 
development and information development testing mode, and as of 
yet, decisions under REACH with respect to chemicals have not 
been made.
    Senator Craig. So from your point of view, you don't know 
that a conclusion can be drawn as to its effectiveness?
    Mr. Gulliford. I think it will be. The effectiveness of 
REACH will at some point in time be known and evaluated and we 
will see the benefits of it.
    Senator Craig. Now, I have portrayed what I think you said, 
Mr. Stephenson, to be fair. Your reaction to the comment of Mr. 
Gulliford.
    Mr. Stephenson. If I could clarify.
    Senator Craig. Please do.
    Mr. Stephenson. TSCA is the regulatory approach.
    Senator Craig. I understand.
    Mr. Stephenson. We are talking about----
    Senator Craig. Well, we are not sure what we are talking 
about.
    Mr. Stephenson. We are talking about standing down the 
toxicity assessments under the IRIS program, which is a 
forerunner of regulation. You have to determine how toxic a 
chemical is, first.
    Senator Craig. I understand.
    Mr. Stephenson. We have other problems with TSCA in that it 
is cumbersome, it requires a two to 10 year test rule in order 
to get information from the chemical industry, information that 
is already provided up front under REACH from the chemical 
industry. So we are kind of mixing apples and oranges here.
    Senator Craig. But in our observation, or excuse me, in 
your observation of REACH, which is a new program in the EU to 
attempt to register and to clarify the value of or the problems 
with 30,000 chemicals, can you at this time assess its quality 
of work and production and its time lines?
    Mr. Stephenson. It is probably too soon to tell, except 
that we get much more information, the Government gets much 
more information from the industry with REACH than it currently 
does under TSCA without heroic efforts. And it is more of a 
partnership with the industry, because the industry understands 
what information it must provide to the regulatory agency. The 
chemical companies here that do business in Europe must 
subscribe to REACH. So it is not foreign for them to handle 
that regulatory framework.
    Senator Craig. So in other words, is it reasonable to 
assume then, in REACH, I can't condemn it yet because I don't 
know about it, or we don't have a track record of its 
effectiveness, where we have chemical companies----
    Senator Boxer. Senator Craig, I just--I am not going to 
stop you----
    Senator Craig. This is the last question.
    Senator Boxer. No, no, no, let me finish. I will give you 
an extra 2 minutes, because I think we will have a second round 
in a few minutes, so you can use your second round now.
    Senator Craig. Then wouldn't it be responsible for us, 
instead of throwing the baby out with the bath water, to look 
at our process and REACH, once it is implemented, through the 
eyes of, in part, of the chemical companies that have to deal 
with both and see which one is the most effective, the most 
transparent, assures proprietaries needs necessary for a 
chemical industry to exist and assures human safety.
    Mr. Stephenson. We are not subscribing the REACH approach. 
What we have done over the last few years is look at TSCA and 
talk about how it is cumbersome to use and how it needs 
overhauling. We have made specific recommendations on our 
legislation, our regulatory approach, on things that need to be 
improved. All we are suggesting is that REACH offers a model 
for front-end information from the chemical industry that we 
might consider as we overhaul TSCA.
    Senator Craig. Thank you. Gentlemen, thank you much.
    Senator Klobuchar, if you want, I will give you 7 minutes, 
that would cover your next round.
    Senator Klobuchar. No, I am just fine.
    Thank you to both of you. I want to follow up on some of 
Senator Craig's questions with you, Administrator Gulliford, 
about the European Union. What I understand, regardless of the 
effectiveness in the long term, is that they are going to be 
receiving a tremendous amount of information on the safety of 
chemicals in the coming years under this new law, which is 
REACH, which standards for Registration, Evaluation, 
Authorization and Restriction of Chemical Substances. So is the 
EPA going to request this information on chemical risks from 
the European program to make sure that our Country has this 
same up to date and current information that they are going to 
have in Europe?
    Mr. Gulliford. Thank you, Senator, that is a very good 
question. In fact, we are working now with the EU members, with 
the EU Commission to make sure that there is a portal that 
allows for access of that information.
    Now, having said that, we believe that it is appropriate 
for us to determine through our process which chemicals we 
believe are most appropriate for our work, for our follow up 
actions with respect to those chemistries. We do believe that 
if the REACH process follows through and generates the data 
that we expect that it will, at a certain point in time, 
because I said to you, we would be committing to completing our 
prioritization work by the year 2012, that we will have at that 
time an opportunity to select from that data that is available 
through REACH. So it is possible that we will use that data. 
But it is also very probable, there are those 30,000 chemicals, 
there will be a lot of those that we won't find a need for that 
data as well.
    Senator Klobuchar. So are you going to get that data in the 
next month, or when are we going to get it? We have a panel 
coming up that is concerned about the health risks here. I know 
we are working through with the EU, but I would think we would 
want that immediately. We have good relations with them.
    Mr. Gulliford. It is industry's obligation to transmit that 
data to the EU between the timeframe of, I believe 2010 and 
2018. So as that data is transmitted, we will know its 
availability. We will also be able to again, by looking at the 
work that we propose to do, not on 30,000 chemicals by on our 
high production or moderate production volume chemicals, 
roughly 7,000, we will have identified the chemicals that we 
believe are most appropriate for action. We will be able to go 
after that data if we do believe that it will be helpful to us.
    Senator Klobuchar. But wouldn't you just rather get the 
data ourselves than have to go through the EU? It seems to me, 
just getting to Mr. Stephenson's point, that we should be, the 
agency itself, which knows the most about this law, should be 
pushing to update our laws so we get that information.
    Mr. Gulliford. We will have access to the data when we need 
it. I think it is more appropriate--it is not our interest to 
be a data manager, it is to be a data user. I think the most 
important thing that we can do at EPA is utilize valuable data 
when we need it in a way that allows us to make effective 
decisions.
    Senator Klobuchar. OK. Mr. Stephenson, do you feel it is 
fair to say that agency officials in Europe are going to have 
access to more information on potential threats from chemicals 
when their new law kicks into gear than we will have in the 
United States?
    Mr. Stephenson. It does under the old law, and they will 
get more under the new law. There is a table in the back of one 
of our TSCA reports that does a side by side comparison of what 
we get under TSCA versus what we get under REACH and the 
Canadian approach, for that matter.
    Senator Klobuchar. And what types of information, I will go 
back and look at that table, but could you give me the greatest 
hits of information they are going to have?
    Mr. Stephenson. It is characteristics of the chemicals, but 
it is also any risk assessment data they have done, any tests 
they have undertaken. They certify to all that data before it 
is provided, before a chemical is approved for production.
    Senator Klobuchar. Could you talk a little bit about the, 
earlier you mentioned the need to update these laws, including 
adequate testing of chemicals, how can we expand that authority 
under TSCA, if we were to look at revamping this law?
    Mr. Stephenson. Are you talking about TSCA or the risk 
assessment process?
    Senator Klobuchar. The risk assessment process.
    Mr. Stephenson. The risk assessment process, again, TSCA is 
a regulatory approach. We are concerned with the scientific 
basis for the regulations that is the IRIS program. We are so 
concerned about OMB involvement here that not only are the 
comments from the interagency review process not given to the 
public like every other piece of science input is given, but 
they are actually dictating which assessments EPA can 
undertake. They had them withdraw five that the Clean Air 
Office wanted.
    Senator Klobuchar. They had them withdraw, what was that?
    Mr. Stephenson. Withdraw assessments on five chemicals that 
were needed by the Office of Clean Air, because they were acute 
assessments, which means short-term assessments that the Clean 
Air Office needed for its Air Toxics program, for example. Mr. 
Gulliford said he uses the data in IRIS and suggests studies 
that were being done. Well, that is exactly what happened, the 
Clean Air Office asked for these, OMB said no, they are not 
important, we are not going to do those.
    So it's not only the transparency in the commenting process 
that is important, it is EPA's independence in controlling 
which assessments they do. The scientists at EPA must have 
independence.
    Senator Klobuchar. And you believe that the transparency, I 
believe as a child of a journalist that transparency is very 
important if you want to get to the truth.
    Mr. Stephenson. It is a principle of sound science.
    Senator Klobuchar. Right, that kind of transparency. It is 
also going to get at decisions that they make, because you 
think that we want to, and Mr. Gulliford claims they are not 
biased in any direction, but that if we want to get all that 
information out there we have to basically open it up.
    Mr. Stephenson. Right.
    Senator Klobuchar. Do you have other examples of other 
agencies from a GAO perspective where they are allowing for 
these comments to be seen?
    Mr. Stephenson. Well, in any scientific risk assessment, 
ask the National Academy, ask the National Science Foundation, 
any scientific body understands the importance of any research 
that is offered, any comments that are made on the risk 
assessment to be available to the public, so the scientific 
community can look at those and decide their worth.
    The fact that after that process is done, it is offered to 
peer review and the public, doesn't forgive that transparency 
in the earlier part of the process. So it is just a cornerstone 
of sound science, and that is why we are so passionate about 
this intervention in the process.
    Senator Klobuchar. I appreciate it, and I also appreciate 
your bringing this out to us in your own manner. I just, when I 
look at the history that we have seen in this Committee with 
the involvement in some of the politics in this science, I have 
always appreciated how people have been willing to come forward 
and tell us we could do a better job if we just had all the 
information out there. I am very hopeful that will change 
within the next year. Thank you.
    Senator Boxer. Thank you.
    Here is what we are going to do. We are going to have a 
second round, and we will start with Senator Barrasso, go to 
Senate Whitehouse, 2 minutes each. And I don't have any further 
questions, so I will just make closing remarks.
    But before Senator Klobuchar leaves, we just got word that 
a Federal judge has found the Bush administration guilty of 
violating the Endangered Species Act and ordered the 
Administration to issue a final listing decision for the polar 
bear by May 15th. The reason I bring it up is that this 
Committee has been on this case for quite a while. I wanted 
everyone to know that. I am pleased about that.
    Senator Barrasso.
    Senator Barrasso. Thank you, Madam Chair.
    Mr. Gulliford, just one last question. On products that are 
already on the market, when it comes to issues of safety risks 
for our children, does the EPA have the appropriate authority 
under TSCA to go back and require new information, promote 
research, require testing on products already on the market? Do 
you feel you have the authority to go do what needs to be done?
    Mr. Gulliford. Yes, we do have the authority to issue test 
rules, yes.
    Senator Barrasso. Thank you, Madam Chairman.
    Senator Boxer. Senate Whitehouse. Senator Whitehouse, I 
will give you a minute of my 2 minutes, so you have three.
    Senator Whitehouse. As I understand it, OMB gets involved 
at the very get-go when nominations as to what drug will be 
considered are first brought forward. Is that what you were 
referring to, Mr. Stephenson, the early decision?
    Mr. Stephenson. I don't know whether that happens 
routinely, but it has happened.
    Senator Whitehouse. Yes. It looks like there is room for it 
right in the process to happen routinely. Then there is an OMB 
interagency review which I think is what we were referring to, 
Mr. Gulliford was referring to a minute ago when he said that 
it was then followed by other public comments on review and 
that provided for some transparency, because you couldn't see 
what they said, you could at least see what change resulted.
    But it looks to me like when you get down here to the 
bitter end, here is OMB again with a second bite at the apple, 
and from there it goes to a reviewed internal assessment that 
address the OMB interagency comment to the EPA for clearance 
and out without any further comment. So I don't see how it is 
true, what you told me, that after the secret OMB input is 
received, there is further opportunity for transparency. It 
looks like that they get the last bite at the apple, don't 
they?
    Mr. Stephenson. Are you asking me?
    Senator Whitehouse. I am asking Mr. Gulliford.
    Mr. Gulliford. I am not familiar with that chart, as I 
indicated, and I would have to examine it to answer that 
question. I will be happy to take that question back and 
provide the Committee with an answer to that.
    Senator Whitehouse. OK. I would appreciate it. Mr. 
Stephenson?
    Mr. Stephenson. The final assessment is shared with the 
public who can then look at the research, but you can't see 
what happened in the steps prior to that. You can't say, the 
DOD offered a new piece of research or something, you can't see 
what that was. If they had a concern, you don't know what it 
was. This is the scientific process.
    The policymaking process is the risk management, when you 
are assigning regulatory approaches. It has no business in this 
part of the process. Now, OMB was saying, we are just 
coordinating via Government agencies the Federal family, as 
they would put it.
    Senator Whitehouse. But there is nothing that you are aware 
of in the process that limits them to that? I mean, if the 
worst case scenario is that a polluter comes to the White 
House, makes big campaign contributions, agrees to be a pioneer 
or whatever it is, and says that they are going to, you know, 
but they want OMB to put the word in for them through this 
process, there is nothing in the process itself that would ever 
disclose that or surface that or prevent that from happening.
    Mr. Stephenson. We have no evidence of that happening. All 
we are saying is that to have complete transparency in the 
process eliminates----
    Senator Whitehouse. I am not suggesting it has happened, 
either. But there is nothing about this process that would 
prevent that or disclose it if it happened at this point.
    Mr. Stephenson. That is our fear.
    Senator Whitehouse. Yes. Thank you.
    Senator Boxer. Thanks, Senator.
    Let me say that, to Senator Craig, who said this hearing is 
just concerned about process and not outcomes, that is wrong. 
The outcomes have already been a disaster, because they put 
this into play without it being officially done. They have 
already put this process into play.
    And what has happened is, EPA itself said they should be 
doing 100 chemicals, regulating over 100 in 2 years, and they 
have regulated 4 chemicals. So outcome, yes. We are not seeing 
the protection of the American people.
    Second, I want to thank GAO from the bottom of my heart for 
doing this for us. This notion that secrecy is going to be 
built into this process, where the American people are the ones 
who will suffer if the wrong decision is made is a complete 
outrage. It goes against the spirit of this whole Country, 
which is openness and trusting its citizens with information.
    Third, shunting scientists aside and putting in front the 
political folks is so obviously a problem that I can't believe 
we are not hearing outcries from my friends on the other side 
of the aisle who, when and if we do get a Democratic President, 
it will be those folks in the room. No one should be in that 
room in the early risk assessment stages at all except the 
scientists and the people concerned about health. Mr. 
Stephenson, if you made any point in a passionate way, that is 
the point.
    There is room for all these other folks as we debate what 
to do. But in the setting of what is safe for our people, it 
has to be pure, done by the people who have no axe to grind, 
who simply have a concern with the science and what it means to 
the health and safety of our people.
    Look, when I go home I hear all the time the fears of my 
constituents about what their kids are being exposed to, what 
their pregnant daughters are being exposed to, what should she 
eat, what should she avoid, what is the problem? I wish I could 
tell them that we have had a stellar, we have done a stellar 
job here. We haven't. It is a nightmare.
    And I will tell you, it is already a nightmare. If this 
process is put into place, it will institutionalize this 
nightmare and set us up for scandal. Because Senator Whitehouse 
said it as clearly as it needed to be said, people are going to 
be represented around that table, and we will never know. And 
Senator Whitehouse, I want you to know, as we struggle to get 
e-mails back and forth on the waiver, we can't get them. And 
you know what the answer is from the Bush White House? You are 
not entitled to these, they are interagency comments.
    So you know, we weren't born yesterday. Well, you can tell 
that from looking at me, I was definitely not born yesterday 
and I do understand that this is a secret process, it is a 
nightmare. And I just want to thank our witnesses for making it 
very clear to us that is the case. Thank you very much.
    We will call up our second and final panel. Professor Linda 
Giudice, who is an M.D., a Ph.D., a Chair of Obstetrics, 
Gynecology and Reproductive Sciences at the University of 
California, San Francisco; Annette Gellert, who is the Co-
Founder and Chair of the WELL Network; V.M. DeLisi, Fanwood 
Chemical, Inc., Synthetic Organic Chemicals Manufacturing 
Association; Laura Plunkett, Ph.D., Integrative Biostrategies, 
LLC, minority witness; Professor Lynn Goldman, she is our 
pediatrician, Chair of the Program in Applied Public Health, 
Johns Hopkins University, former Clinton EPA Assistant 
Administrator for Pesticides and Toxic Substances.
    Well, those were such long introductions you have time to 
actually have a seat. So we will go forward, and we will ask 
Dr. Giudice to address us on this. We will give you each 5 
minutes and then we will have lots of time for questions.

STATEMENT OF LINDA C. GIUDICE, M.D., PH.D., MSC., PROFESSOR AND 
 CHAIR, DEPARTMENT OF OBSTETRICS, GYNECOLOGY AND REPRODUCTIVE 
       SCIENCES, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

    Dr. Giudice. Thank you. Good morning, Chairman Boxer and 
Committee members. Thank you for the opportunity to provide 
testimony at this important hearing today, where I shall focus 
on three things: one, disturbing trends about male and female 
reproductive health and development; two, how chemicals in our 
environment can affect these; and three, preserving health now 
and for future generations.
    During my career as a reproductive endocrinologist and 
infertility specialist, I have treated thousands of patients 
with infertility and reproductive disorders: young men with 
abnormal sperm, teens into menopause, little girls with puberty 
at 6 years old and women with endometriosis, uterine fibroids, 
incapacitating pain, infertility and miscarriage. We do not 
know the underlying causes for most of these disorders, but 
increasing scientific evidence suggests that environmental 
contaminants play a role.
    Five years ago, one of my patients questioned whether her 
exposure to environmental chemicals as a child growing up near 
a PCB-contaminated site on the East Coast could play a role in 
her infertility. For me, this was a wake-up call, because we 
know that hormones can affect human development and some 
environmental chemicals at like hormones.
    There are disturbing trends in the United States. The 
percentage of women in their peak time of fertility, less than 
25 years of age, who report difficulty in conceiving and 
maintaining pregnancy, has doubled from 4.3 to 8.3 percent 
between 1982 to 2002. Over the past 50 years, sperm counts have 
decreased by 50 percent in industrialized regions. Compared to 
30 years ago, over 25 percent more women get breast cancer, 45 
percent more men get testicular cancer and 76 percent get 
proState cancer. Thirty percent more babies are born 
prematurely, and among the most common birth defects today are 
malformations of the male reproductive system.
    Scientific evidence highly suggests that exposures in the 
womb or in early childhood to environmental contaminants can 
cause in humans some of these trends, including birth defects, 
pre-term birth, low birth weight, learning disabilities, 
childhood cancers and later effects as adults, diabetes, 
obesity, heart disease, infertility and cancer. So adult 
disorders happening because of exposures in utero.
    Since World War II, nearly 90,000 chemicals have been 
produced and there is ubiquitous exposure to environmental 
contaminants in our air, water, food, drink, cosmetics, 
personal care products, pesticides and everyday household 
products. Exposure to these around the time of conception, 
during pregnancy or infancy can be particularly powerful 
because these are times of special vulnerability, where 
important developmental changes are taking place. These 
exposures can also affect subsequent generations.
    For example, bisphenol A, a chemical that is in can linings 
and present in nearly every one in the U.S., can have such an 
effect. Dr. Pat Hunt at Washington State showed that female 
fetuses of BPA-exposed pregnant mice had damaged eggs and 
abnormal chromosomes. Abnormal chromosomes are a leading cause 
of miscarriage, congenital defects and mental retardation in 
humans. The study also showed the prenatal BPA exposure 
resulted in damage across generations.
    Another example is phthalates, common in personal care and 
vinyl products. Exposure during pregnancy can lower fetal 
testosterone, a hormone important for male reproductive tract 
development. In animals, this is linked to undescended 
testicles and deformed penis at birth. Dr. Shanna Swan has 
shown that pregnant women with higher phthalates have a greater 
risk of having little boys with decreased genital dimensions, 
supporting effects on the male system in the human.
    Exposure to chemicals like these interferes with proper 
functioning of the endocrine system, raising concern among 
health care providers and scientists, and others include 
pesticides, solvents and heavy metals. So what to do?
    We need to ensure that couples can conceive if they wish 
and have a healthy pregnancy and healthy children and 
grandchildren. We need the Federal Government to fulfill its 
mission, assemble existing scientific knowledge, impartially 
reviewing it in an unbiased manner following scientific 
principles free of ideology. For some chemicals we have 
scientific data, but for many, we do not. And the absence of 
data doesn't mean that a chemical is safe, it just means that 
we have no data.
    For these chemicals, we need actions that require providing 
sufficient information so our Government can move forward to 
prevent harmful exposure and by acting now, to guarantee the 
health of our children and our grandchildren and generations to 
come.
    My thanks go to the Society for Women's Health Research, 
our UCSF Program on Reproductive Health and the Environment, 
the Reproductive Health Technologies Project, and the American 
Society for Reproductive Medicine, for their help in preparing 
this testimony. Thank you.
    [The prepared statement of Dr. Giudice follows:]



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       Responses by Hon. James Gulliford to Additional Questions 
                           from Senator Boxer

    Question 1. Dr. Giudice. please describe how sensitive the 
human reproductive and other hormone controlled systems can be 
to toxic chemicals during periods of particular vulnerability, 
such as pregnancy or when infants are rapidly developing in the 
first few years after birth?
    Response. Critical and sensitive windows occur 
periconceptually (prior to, during and shortly after the 
fertilization of the egg) and during pregnancy; infancy, 
childhood and puberty (Woodruff et al. 2008). A critical window 
of susceptibility is a time-sensitive interval during 
development when exposures to environmental contaminants can 
disrupt or interfere with the physiology of a cell, tissue or 
organ (Louis In Press; Morford et a!. 2004). It is a period 
characterized by marked cellular proliferation and development 
and numerous changing metabolic capabilities in the developing 
organism (Calabrese 1986; Louis In Press). Exposures to 
environmental contaminants during this window may result in 
adverse, permanent and irreversible effects that can have 
lifelong and even intergenerational impacts on health. 
Researchers have suggested the need to also define sensitive 
windows of susceptibility. Exposures during sensitive windows 
of susceptibility may still affect development or result in 
eventual adult disease, but with reduced magnitude compared to 
the effect of exposure during the critical window of 
susceptibility (Ben-Shlomo and Kuh 2002; Louis In Press). For 
example, diethylstilbestrol (DES) exposure reprograms the 
expression of estrogen responsive genes in Eker rats exposed on 
post-natal days 3-5 or 10-12 (critical window of 
susceptibility). leading to increased incidence of uterine 
leiomyoma. In contrast, rats exposed on post-natal days 17-19 
(sensitive window of susceptibility) did not experience this 
developmental programming and had a rate of uterine leiomyoma 
that was elevated but not statistically different from control 
animals (Cook et al. 2007).


                            the des example


    Prenatal exposure to DES, a synthetic estrogen and thus an 
endocrine disrupting chemical (EDC), provides an unfortunate 
example of the influence of exposure to an endocrine disrupting 
compound during a critical window development. DES was given to 
U.S. pregnant women between 1938 and 1971 under the erroneous 
assumption that it would prevent pregnancy complications. In 
fact, in utero exposure to DES alters the normal programming of 
gene families, such as Hox and Wnt, that play important roles 
in reproductive tract differentiation (Miller et al. 1998; 
Pavlova et al. 1994; Taylor et al. 1997; Woodruff and Walker In 
Press).
    As a result, female offspring exposed to DES in utero are 
at increased risk of clear cell adenocarcinoma of the vagina 
and cervix, structural reproductive tract anomalies, 
infertility and poor pregnancy outcomes, while male offspring 
have an increased incidence of genital abnormalities and a 
possibly increased risk of proState and testicular cancer 
(Schrager and Potter 2004). These observed human effects have 
been confirmed in numerous animal models which have also 
provided information on the toxic mechanisms of DES. Animal 
experiments have also predicted changes later found in DES-
exposed humans. such as oviductal malformations (Newbold et al. 
1983), increased incidence of uterine fibroids (Baird and 
Newbold 2005; Cook et al. 2005; McLachlan et al. 1980) and 
second-- generational effects (Newbold et al. 1998, 2000) such 
as increased menstrual irregularities (Titus-Ernstoff et al. 
2006) and ovarian cancer (Blatt et al. 2003) in DES-
granddaughters and increased hypospadias in DES-grandsons 
(Brouwers et a!. 2006; Klip et a!. 2002).
    DES is but one example of how exposure to EDCs can disrupt 
developing organ systems and cause abnormalities that only 
appear much later in life or in the subsequent generation 
(Colborn et al. 1996). Other examples include: prenatal 
exposure to bisphenol a, an estrogenic chemical, in mice 
resulted in effects on the daughters developing eggs (Susiarjo 
and Hunt In Press), and prenatal exposure to phthalates, an 
anti-androgenic chemical, can result in adverse effects on male 
reoproductive development such as poor sperm quality and 
increased incidence of cryptorchidism (undescended testis) and 
hypospadias (abnormal penis development) (Woodruff et at, under 
review).

    Question 2. Dr. Giudice. could you please explain the 
importance of considering human exposures to multiple chemicals 
on very delicate biological systems. like the human endocrine 
system?
    Humans are exposed daily to a mixture of environmental 
contaminants in air, water and food. In a recent biomonitoring 
study of over 150 contaminants, the U.S. Centers for Disease 
Control and Prevention (CDC) reported that all 150 chemicals 
were detected in some portion of the U.S. population and that 
several of the chemicals, such environmental tobacco smoke, 
lead, mercury and phthalates, are detected in nearly all or all 
of the population (CDC 2005). These and similar biomonitoring 
efforts improve our understanding of current body burdens of 
environmental contaminants. With this knowledge comes a need 
for better science on the health risks associated with current 
patterns of exposure, including increased risks resulting from 
exposures to multiple chemicals. For example, the majority of 
studies and regulatory focus have been on exposures to 
individual phthalates, which may underestimate the actual 
risks. Over 95 percent of the population from ages 6 and to 
over 65 years is exposed to at least 5 phthalates on a regular 
basis (Silva et at 2004). Certain phthalates can inhibit 
testosterone synthesis, thus decreasing testosterone levels. 
Reducing testosterone levels in rats during in utero 
development can results in adverse effects on male reproductive 
development including decreased sperm counts, decreased ano-
genital distance, hypospadias, cryptorchidism, and decreased 
size or agenesis of the accessory sex glands (Woodruff et aI., 
under review). The severity of effects increases with the dose.
    Recent studies show exposure to mixtures of chemicals that 
can reduce testosterone levels can have dose-additive effects. 
Rats exposed to a mixture of pesticides that can decrease 
testosterone levels, vinclozolin, procymidone, and f1utamide, 
at doses that would not have caused hypospadias alone, resulted 
in over 50 percent of animals with hypospadias (Christiansen et 
al. 2008). Another study found prenatal exposure to a mixture 
of seven phthalates and pesticides produced cumulative, dose 
additive outcomes in the androgen-dependent tissues (Rider et 
al. 2008).
    A study of the thyroid system has found similar results. A 
study of a mixture of 18 thyroid disrupting chemicals (dioxins, 
dibenzofurans and PCBs) was tested at doses comparable to human 
exposure levels for effects on thyroid hormone levels in rats. 
The mixture had a dose-additive effect on thyroid hormone 
levels at environmentally relevant doses and a 2-3 fold greater 
than dose-additive effect at higher doses (Crofton et al. 
2005).
    The studies show that chemicals acting on the same system 
can have cumulative effects. Assessments considering single 
chemicals in isolation are therefore likely to underestimate 
the potential effects from real-world exposure to chemical 
mixtures (Woodruff et aI., under review).
    Finally. biomonitoring data indicate that more effort is 
needed toward approaches that identify and mitigate exposure to 
harmful chemicals prior to measuring these contaminants in 
people.

    Question 3. Dr. Giudice. as a public health professional 
and scientist. how important is transparency in ensuring a 
valid and strong scientific process?
    Response. To make informed decisions. it is critical we 
have the best science available to inform what we know and what 
we do not know about how environmental chemicals can influence 
health. Science is an iterative process, as scientific inquiry 
moves forward, further insights are gained and new questions 
arise. Capturing and translating the complexities of the 
science is an ongoing challenge in the regulatory and policy 
arena. While science pursues new areas of inquiry, decision 
making requires timely answers to questions about risks and 
hazards to public health in order to mitigate future or current 
potential harm (Woodruff et aI., under review). Regulatory 
context also requires a different sufficiency of evidence. For 
example, it is not necessary to identify every mechanistic step 
leading from exposure to outcome to make decisions that 
consider public health. For example, regulatory decisions are 
often made based on evidence that a chemical is ``likely'' to 
cause a particular outcome, such as cancer. Transparency is an 
important part of the scientific process--it allows full 
evaluation of the methods and protocols used from which 
conclusions are drawn. Without transparency, we cannot fully 
evaluate the findings from studies nor the conclusions, and 
this limits our ability to make informed decisions.

    Question 4. Dr. Giudice. at the hearing. another witness 
raised questions about some of the data you relied upon in your 
testimony. Would you please elaborate on the scientific 
information you relied upon in your statements. with citations 
to the literature?
    Response. In the beginning of my testimony, I referred to 
some concerning trends in reproductive health. The sentence and 
references are below: Compared to 30 years ago, over 25 percent 
more women get breast cancer (NCI 2004), over 45 percent more 
men get testicular cancer (Bray et al. 2006; Sokoloff et al. 
2007), and 76 percent more men get proState cancer (Penson and 
Chan 2007).

    Senator Boxer. Thank you very much, Doctor.
    Our next majority witness is Annette Gellert, Co-Founder 
and Chair of WELL Network. Welcome.

           STATEMENT OF ANNETTE GELLERT, CO-FOUNDER, 
                      CHAIR, WELL NETWORK

    Ms. Gellert. Good morning, Chairman Boxer, members of the 
Committee. Thank you for this opportunity to testify.
    My name is Annette Gellert. I am a wife and the mother of 
three children. I am a Founder of the WELL Network, which 
promotes green planning, a comprehensive process between 
industry, government, scientists and informed citizens to solve 
together environmental health problems.
    I am also Chairman of Resource Renewal Institute, whose 
Green Plan Center researches advanced environmental management 
strategies.
    After a bill was introduced in California concerning 
biomonitoring, I wanted to know what potentially toxic 
chemicals might be inside my family. My family and I had our 
blood tested in 2006 by the Environmental Working Group to 
determine possible exposure to 70 toxic chemicals. I was 
alarmed to find out that I had 36 chemicals in my body and 
shocked that my 16 year old daughter, Heather, had 34 chemicals 
in hers. There were similar results in the rest of the family. 
Heather has been on the planet for such a short time, yet she 
lives in a much more toxic environment.
    Of the chemicals that were found in our bodies, some have 
already been restricted in the European Union. These chemicals 
are suspected of being harmful to the thyroid, as well as 
reproductive and neurological systems. I am worried about my 
children's health. I am worried about my children's ability to 
reproduce. I am worried about the health of their children, our 
grandchildren. I am not alone.
    I will do everything in my power to protect my children and 
I am here to ask you to do the same. I am a reproductive cancer 
survivor, cancer of the placenta is what I had. Too many of my 
friends are fighting cancer. While I was preparing for this 
hearing, I got very bad news. My husband, Fred, was diagnosed 
with bladder cancer. We are going through that now.
    A known cause of bladder cancer is industrial chemical 
exposure. No doubt many of you in this room have similar 
stories. The cancer rate keeps going up.
    There is mounting evidence that numerous chemicals in our 
environment are seen as contributors to illness. Some of them 
are known carcinogens. When my children needed Tylenol in 
school, it required my written permission. When they are 
exposed to chemicals, it happens without my permission and 
without my knowledge.
    We come into contact with toxic chemicals all the time, 
from cosmetics to electronics to cleaning agents to plastic 
containers to children's toys to baby bottles and teethers. We 
are exposed to harmful chemicals in every aspect of our lives. 
We have had no choice in our past exposures and continue to 
have little choice now.
    Only a very small percentage of chemicals have been tested 
for toxicity. We are in a crisis. America needs a new approach, 
a proven, better way, green planning. The key to progress is 
building trust that promotes cooperation between sectors, 
Government, industry, science and an informed public. This 
strategy is working very well in other countries, where it has 
been in action for nearly 20 years, creating environmental and 
economic success.
    And now the EU has introduced REACH, a new integrative 
chemicals policy which is already having an effect, setting the 
terms for global markets and manufacturing and market access. 
We are not scientists or chemists. Our concerns represent 
millions of other women who fear the impact of products we use 
daily. There is virtually no information we can trust on 
whether products are safe or not. We need to make those 
decisions by ourselves.
    There is no American scientific body that has assessed all 
chemicals in common use to determine their impact on human 
health and no place to get that information. We are greatly 
concerned that by falling behind other countries' regulations, 
the United States will become the dumping ground for all the 
products that cannot be sold in Europe. Because their 
regulations are stricter than ours.
    In the United States, we must prove harm before a product 
is removed. In Europe, industry must prove safety before a 
chemical is introduced. We urge you to protect us and start 
this process by looking at chemicals in a comprehensive way. It 
is the right thing to do.
    Thank you.
    [The prepared statement of Ms. Gellert follows:]



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    Senator Boxer. Thank you so much for your moving testimony.
    Mr. DeLisi, Fanwood Chemical, Inc., Synthetic Organic 
Chemical Manufacturers Association, minority witness, welcome, 
sir.

             STATEMENT OF V.M. DeLISI, PRESIDENT, 
                     FANWOOD CHEMICAL, INC.

    Mr. DeLisi. Good morning, Chairman Boxer and distinguished 
members of the Committee. My name is Jim DeLisi, I am President 
of Fanwood Chemical, located in Fanwood, New Jersey, and I 
might add, the proud father of two grown daughters and a 
grandfather of one.
    I have been employed by Fanwood Chemical for over 30 years, 
and have specialized in the marketing of organic chemical 
intermediates in North America as well as Europe and South 
America. In addition, I have been heavily involved in trade 
issues that impact our industry. I have served as chairman of 
the Synthetic Organic Chemical Manufacturers Association, 
better known as SOCMA's International Affairs Committee for 
many years. In addition, I am the Chairman of ITAC 3, the 
Industry Trade Advisory Committee for Chemicals, 
Pharmaceuticals, Health Science Products and Services 
administered jointly by the United States Department of 
Commerce and the United States Office of the Trade 
Representative.
    Thank you for this opportunity to share with you my 
company's perspective on current chemical risk management 
regulations and initiatives by the U.S. Environmental 
Protection Agency. My remarks will also address generally 
significant concerns about Congress moving in the direction of 
adopting over-reaching regulatory schemes, such as Europe's 
Registration, Evaluation, Authority and Restrictions of 
Chemicals Program, better known as REACH.
    Fanwood Chemical currently has two full-time employees and 
two part-time employees working from our offices in Fanwood, 
New Jersey. We also have a working relationship with senior 
members of our industry for help on special projects. The 
products we sell are primarily used to make color or are 
functional additives in lubricating fluids. In these instances, 
we are responsible for bringing to the marketplace products 
produced in U.S. manufacturing facilities and are backed up by 
their staffs.
    We are also experts in REACH and the business challenges 
this program presents, with special emphasis on its impact on 
non-EU based companies. This combination of activities has 
required us to have a working knowledge of EPA's Toxic 
Substances Control Act, the Federal Insecticide, Fungicide, 
Rodenticide Act and many other EPA programs, as well as similar 
programs in countries where we have direct exports. We also are 
knowledgeable in programs for countries where have indirect 
exports, i.e., our customers export our products to those 
lands.
    Fanwood Chemical was founded by my father, Vince DeLisi, in 
1971. He could have very successfully completed his career in 
the chemical industry without at all ever leaving the shores of 
the United States. However, the primary industry we were 
serving at the time was the manufacturers of dyestuffs, so I 
clearly could not have had a successful career only within the 
bounds of the United States. Therefore, in 1980, we began to do 
business in the international arena, first into Europe. It was 
a challenge then and continues to be a challenge today to sell 
U.S.-produced goods internationally because of severe 
competition we face from all over the world.
    Since 1976, thousands of chemicals have been evaluated by 
the U.S. Environmental Protection Agency under the Toxic 
Substances Control Act for potential human health and 
environmental effects. American chemistry has invested and 
continues to invest significant resources to assure that 
products we sell meet rigorous regulatory standards and do not 
present an unreasonable risk to the health of the environment. 
To the contrary, in fact, chemicals produced by SOCMA members 
daily improve the lives of millions of Americans. These 
chemicals assist the young and the elderly alike, helping the 
healthy to stay well and the sick to recover. Other chemicals 
produced by industry go toward defending our Nation against 
terrorism, enabling American workers to perform their jobs 
safely and transporting millions of travelers across our 
Nation. We are also confident that chemistry will likely be the 
key to solutions to minimize global warming. All of these 
benefits are made possible by the appropriate balance in our 
existing system of chemical control regulation and the vast 
commitments of chemical industry resources to product 
stewardship.
    I urge this Committee to thoughtfully consider whether it 
is really necessary or wise to adopt a monolithic new 
regulatory regime for chemical regime like the EU's REACH, 
Registration, Evaluation, Authorization and Restriction of 
Chemicals, program. In our view, existing EPA regulation and 
voluntary initiatives are sufficient and far more appropriate 
than REACH, to control possible hazards and still preserve the 
sustainability of America's third largest manufacturing 
industry.
    Our industry accepts our responsibility to profitably make 
products that are safe under expected exposure conditions, an 
obligation that EPA polices under TSCA. But Congress has also 
established a policy in TSCA that chemical regulations should 
not impede unduly or create unnecessary economic barriers to 
technological innovation. This balance of regulatory burdens 
and public benefit is crucial for small American business which 
would be hit hardest by a REACH-type scheme.
    A common assumption that chemical companies each employ 
thousands of workers and have unlimited resources are myths. 
Seventy percent of SOCMA members, many of which operate in New 
Jersey, are classified as small business by the Federal 
Government. Though not a manufacturer in the pure definition, 
Fanwood Chemicals sells chemicals domestically and abroad to 
manufacturers that produce end-use products. Manufacturers 
large and small rely on companies like mine to source chemicals 
on their behalf, enabling them to reliably meet American 
consumers' demand for their products. In a major way, Fanwood 
Chemical and the many small companies like it represent the 
underpinnings of the industry. Although we are small, our 
regulatory obligations are very similar----
    Senator Boxer. Sir, I want you to conclude.
    Mr. DeLisi. OK.
    Senator Boxer. Yes.
    Mr. DeLisi. We believe that an American REACH would not 
only hamper innovation but reverse the progress made over the 
course of many years by Federal regulators in the chemical 
industry. Thank you for this opportunity to share with you 
Fanwood Chemicals' perspectives on these issues.
    [The prepared statement of Mr. DeLisi follows:]



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    Senator Boxer. Thank you very much.
    Next is Dr. Laura Plunkett, Ph.D., Integrative 
Biostrategies, LLC, a minority witness. Welcome.

   STATEMENT OF LAURA M. PLUNKETT, PH.D., DABT, INTEGRATIVE 
                       BIOSTRATEGIES, LLC

    Dr. Plunkett. Good morning, Madam Chairman and Senators. I 
want to thank you for the opportunity to be here today to speak 
to you.
    My name is Dr. Laura Plunkett. I am a pharmacologist, 
toxicologist and a human health risk assessor. In my job every 
day I look at these issues related to what chemicals in our 
environment are affecting our health. I work for industry 
sometimes, but I also work for individuals, and often give 
advice to individuals or work on cases where individuals have 
been harmed by chemicals or by individual consumer products. So 
I can look at this from both perspectives.
    My testimony today is related to the adequacy of current 
risk assessment methods and regulatory programs to evaluate 
chemicals and identify risks to sensitive populations in the 
human population. That includes the developing fetus, infants 
and children. I would like to say that this testimony reflects 
my views, not the views of my clients.
    The first thing I want to do is briefly define risk 
assessment, even though a former witness did that for us. Risk 
assessment is a process, a multi-step process within the 
regulatory environment. Risk is defined as the probability that 
any injury, disease or health effect, even something as 
terrible as death, will occur from contact or exposure to a 
chemical. I am going to limit my comments to chemical risk 
assessment today.
    It is a four-step process involving hazard identification, 
dose response assessment, exposure assessment and risk 
characterization. Each part of the process is very important in 
being able to determine whether or not something we are exposed 
to is truly going to harm us.
    There is a large body of published, peer-reviewed 
scientific literature available that speaks to the adequacy of 
our current risk assessment process that is used by EPA to 
protect human health. The large body of studies and information 
out there speaks specifically to the health and the protection 
of the health of sensitive human sub-populations, such as the 
fetus, infants and children. I have reviewed and analyzed this 
large body of information over the years I have worked as a 
consultant, and I would like to speak just very briefly to a 
few of the key points or principles that I think you can glean 
as a scientist looking at this literature.
    The first point, as I think everyone is aware, children are 
not little adults. Age and stage of development are extremely 
important to risk assessors. We use those things as 
considerations in our process. Children, while not being little 
adults, their sensitivity to chemical exposure is highly 
dependent on the nature of the chemical. There are chemicals 
where children are more sensitive and are the population of 
concern for the risk assessment. There are chemicals where in 
some cases it is a different population, the elderly, for 
example, that may be of most concern. In some cases, children 
can actually be less sensitive than the mature human adult to 
the exposure to the chemical.
    Age is not the only factor that contributes to differences 
among humans in the response to chemical exposures. Gender, 
genetics and health status are also very important, and in some 
cases, more important than the age. Exposure, however, is one 
of the most critical components in the process. We know that 
there are a lot of data showing that children can be exposed to 
a greater extent to chemicals in their environment, due to 
things that they do daily in their environment. All of those 
things are currently employed and used as part of the risk 
assessment process. We do children-focused or child-focused 
parts of our assessment when a child is the receptor or the 
individual that is of concern to the risk assessment.
    If you do an analysis and look at the studies overall, and 
try to do what I call a weight of the evidence approach to 
examining the published literature, you can see that the 
methods that EPA currently uses for its risk assessment indeed 
give a risk assessor some confidence that the developing fetus, 
infants and children are being protected. Remember that the 
methods we are looking at include consideration of differential 
sensitivity, not only to toxicity, but also on the exposure 
side.
    Current risk assessment methods for chemicals employ 
tiered-testing strategies as a common thing that we see today. 
That is what the current regulations use. They allow the risk 
assessor to look at the fact that resources are being focused 
on evaluation of the chemicals of most concern and also looking 
at the population of most concern. They allow you to prioritize 
the chemicals for further testing. That is an important part of 
the process.
    So when I look at this data and also the regulations that 
are currently in place, as a scientist, I believe that we can 
have some confidence that we are protecting the fetus, infants 
and children with the approaches that are currently in place.
    This fact, combined with the fact that we know that hazard 
is not the only part of the equation, but also we need to know 
something about the exposure and the overall risk of the 
chemical that we look at, that is an important part of the 
equation is well.
    Enforcing a chemical regulation is also a focus. I think 
that is part of the process. When you look at TSCA, if 
enforcement is done as can be done, indeed I think that the 
chemical regulatory process can be complete and protective of 
human health for all sub-populations.
    I have a few seconds and I just wanted to make a couple of 
comments to some of the things that I have heard before.
    Senator Boxer. Actually, you have gone over. You have gone 
31 seconds over, but if you want you can go another 30 seconds. 
Go right ahead.
    Dr. Plunkett. I just wanted to say that in some of the 
comments that I have heard, and some of the studies and some of 
the statistics that have been brought up by the other 
witnesses, as a scientist, I am not aware that some of those 
statistics are indeed true. I would encourage people on the 
panel to use----
    Senator Boxer. What statistics?
    Dr. Plunkett. Some of the statistics about the rate of 
cancer incidence increasing, the level that it has increased 
over the years. I think if you look at the literature, those 
numbers, at least the numbers that I am aware of are not 
supported by the scientific literature, at least. I will end it 
there.
    [The prepared statement of Dr. Plunkett follows:]



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        Response by Laura M. Plunkett to an Additional Question 
                           from Senator Boxer

    Question. Plunkety during the hearing, you stated that, 
``as a scientist, I am not aware that some of those statistics 
are indeed true. `` When I asked you which statistics. you 
answered, ``Some of the statistics about the rate of cancer 
incidence increasing, the level that it has increased over the 
years. I think if you look at the literature. those numbers. at 
least the numbers that I am aware of are not supported by the 
scientific literature, at least. `` Please answer the following 
questions concerning your statement:
    Did you know that the National Cancer Institute. which is 
part of the US National Institutes ofHealth. states: ``Over the 
past 20 years. there has been some increase in the incidence of 
children diagnosed with all forms of invasive cancer. from J1.5 
cases per 100,000 children in 1975 to 14.8 per 100,000 children 
in 2004."
    Did you know that the America Cancer Society, which has 
funded $3 billion in cancer research--including funding the 
work of 42 Noble Prize winners--estimates that ``[s]ince the 
early 1970's, incidence rates of... (non-Hodgkin lymphoma) have 
nearly doubled. ''
    Response. Senator Boxer, I am aware of the sources you have 
listed above and in fact they are some 
ofthesamesourcesIreferredtoinmyletter ofMay 
1,2008toSenatorInhofewhereI suggested that statistics for 
cancer incidence can be found in some reliable data bases such 
as the NCI. In that letter. I mentioned two documents that 
provide summaries of trends in cancer incidence over time 
available from NCI (e.g., Ries, L.A.G. et al. (eds). SEER 
Cancer Statistics Review, 1975-2005. National Cancer Institute. 
Bethesda. MD. http://seer.cancer.gov/csr/1975--2005/, based on 
November 2007 SEER data submission, posted to the SEER web 
site, 2008; Ries, L.A.G. et al. (eds). Cancer Incidence and 
Survival among Children and Adolescents: United States SEER 
Program 1975-1995, National Cancer Institute, SEER Program. NIH 
Pub. No. 99-4649. Bethesda. MD, 1999).
    As I stated, both of these documents are reliable, 
authoritative sources accessed by scientists when wanting to 
understand trends in cancer incidence in the U.S. I believe 
that review of these two documents reveals that the statistics 
cited at the hearing on April 29th are not supported by the NCI 
data. In general. cancer incidence overall has remained 
somewhat stable over the last 30 years, with some regional. age 
group. and racial variations. I would refer anyone interested 
in citing a cancer incidence rate to those sources. with one 
document specific to childhood cancers. I also believe that 
these two documents would be good resources for the Committee 
as they try to understand the incidence of cancer. As I do not 
know where your statistics above are actually derived from, as 
you have not provided me with the citations in your question 
above, I cannot respond specifically to your values. I would 
again reiterate, however, that the NCI indicate that the 
overall incidence of cancer has remained somewhat stable and 
that any trends in certain regional or age group statistics 
must be carefully considered in light of Ms. Heather Majors 
September 2, 2008 confounding factors such as changes in 
diagnostic criteria or screening? factors that often are 
responsible for purported increases.

        Response by Laura M. Plunkett to an Additional Question 
                          from Senator Inhofe

    Question. Dr. Plunkett, there appeared to be some confusion 
during the hearing about a comment you made about the ``rate of 
cancer incidence increasing''. I believe you stated:

    ``Some of the statistics about the rate of cancer incidence 
increasing, the level that it has increased over the years. I 
think if you look at the literature, those numbers, at least 
the numbers that I am aware of are not supported by the 
scientific literature, at least. I will end it there. `` I 
believe you were making the point that the rate of increase may 
not be as great as others suggested, not that the rate was 
decreasing. Is this correct and please elaborate.

    Response. Senator Inhofe, you are correct in your 
suggestion above regarding my statements. During the hearing it 
was erroneously asserted that I had testified that cancer rates 
in the U.S. are decreasing. What I was actually addressing in 
my testimony and answers to questions was the need to assure 
that any statistics on disease incidence that were presented at 
the hearing be based on sound science and not merely statements 
made for impact without a basis in actual scientific data. 
During the hearing I was concerned and raised questions when I 
heard statistics being mentioned that based on my experience, 
were not reflective of the actual incidences of cancer and the 
changes in sperm count in the U.S.
    It is important to realize that data on something such as 
cancer incidence are complex. Statistics can be reported based 
on yearly incidence, incidence over time, incidence broken out 
by sex, age at diagnosis, mortality, etc. A scientist must 
consider whether any statistics collected are representative of 
the population of concern. The best source of such data for 
describing the U.S. population would be data collected in the 
U.S. Such an authoritative source would be the National Cancer 
Institute (NCI), which is a part of the National Institutes of 
Health, Department of Health and Human Services. Although I 
have not had time to do an exhaustive search of all the data 
available, there are several summaries of trends in cancer 
incidence over time available from NCI (e.g. Ries, L.A.G. et 
al. (eds). SEER Cancer Statistics Review, 1975-2005, National 
Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/
1975--2005/, based on November 2007 SEER data submission, 
posted to the SEER web site, 2008; Ries, L.A.G. et al. (eds).
    Cancer Incidence and Survival among Children and 
Adolescents: United States SEER Program 1975-1995, National 
Cancer Institute, SEER Program. NIH Pub. No. 99--4649. 
Bethesda, MD, 1999). Both of these documents are reliable, 
authoritative sources accessed by scientists when wanting to 
understand trends in cancer incidence in the U.S. Review of 
these two documents reveals that the statistics cited at the 
hearing on April 29th are not supported by the NCI data. In 
general, cancer incidence overall has remained somewhat stable 
over the last 30 years, with some regional, age group, and 
racial variations. I would refer anyone interested in citing a 
cancer incidence rate to those sources, with one document 
specific to childhood cancers.
    With respect to sperm counts in the U.S., there is no one 
source of data that I can point to for reference. However, one 
authoritative source, the World Health Organization 
International Program for Chemical Safety (WHO/IPCS), did 
perform a comprehensive review of the issue of endocrine 
disruption (including sperm count issues) in 2002 (IPCS. 2002. 
Global assessment of the state-of-the-science of endocrine 
disruptors. Geneva: World Health Organization). The WHOIIPCS 
concluded that with respect to the hypothesis that there may be 
a global reduction in human semen quality (including sperm 
count) that might be related to environmental exposures to 
chemicals acting as endocrine active substances, there is not a 
global trend for declining semen quality that can be identified 
based on considering all of the available data. They found that 
although some studies showed declines in certain regions or 
cities, other studies found no evidence of such decline, 
suggesting there may be regional trends but not a global trend. 
Therefore, this authoritative source does not support the 
statistic quoted in the hearing related to sperm count 
declines.
    As I also stated in my previous letter, I strongly believe 
that science should not be used as a political tool to support 
one position or another, but should be used as part sofa 
decision making process. In this case, it is not sound science 
to use statistics that are not reflective of the appropriate 
population, or are reflective of only one study when there is 
body of evidence to consider.

    Senator Boxer. We will get--it depends on the type of 
cancer, but we will get that information into, we will go to 
the Cancer Institute doctor and we will put those in the 
record. So wherever that will fall.
    Dr. Lynn Goldman, we welcome you, M.D., Chair, Program and 
Applied Public Health at Johns Hopkins, former Clinton EPA 
Assistant Administrator for Pesticides and Toxic Substances. 
Also a pediatrician, I understand. We welcome you, a majority 
witness. Go right ahead.

    STATEMENT OF LYNN R. GOLDMAN, M.D., M.P.H., PROFESSOR, 
   ENVIRONMENTAL HEALTH SCIENCES, JOHNS HOPKINS UNIVERSITY, 
               BLOOMBERG SCHOOL OF PUBLIC HEALTH

    Dr. Goldman. Chairman Boxer and members of the Committee, I 
really appreciate your interest in this issue. I think that the 
regulation of chemicals by EPA is a very important area.
    In 1976, when the Toxic Substances Control Act was passed, 
there were great hopes by Congress for what it might do. 
Unfortunately now, 32 years later, one must acknowledge that 
this Act needs to be revised, in particular, to protect 
children. Chairman Boxer, I know that you have had a major role 
in legislation to protect the health of children. Your 
colleague, Senator Lautenberg, talked about the Kids Safe 
Chemical Act, which I think has been a wonderful effort.
    I understand, as a former regulator of the chemical 
industry, the way that chemicals play a vital role in the 
economy. They are very important in our society and I would not 
underestimate that. But I think I also understand that strong 
regulation is needed to assure the health of all our citizens, 
especially our children.
    Today I am here to address the concerns about EPA's IRIS 
program. What is this program about? It was mentioned earlier 
that the dose makes the poison. What IRIS is about is 
establishing what that dose is that makes the poison, so that 
everybody in society, whether it is regulators, doctors, 
States, industry, will know what EPA's views are about that 
does. I don't think any of us here today are saying that any 
level of exposure to any chemical is of concern. We want to 
know what the levels that are safe and what levels are of 
concern. That is what IRIS is all about.
    I have been studying formaldehyde, and I think it is an 
example that helps to understand about why this is important. 
You know that formaldehyde is used extensively in the 
manufacture of wood and wood products. For many years, it has 
been considered to be a probable human carcinogen. But in 2006, 
IARC, the International Agency for Research and Cancer, made a 
determination that formaldehyde is known to cause cancer in 
humans, does actually cause cancer in humans. This is a very 
difficult threshold of evidence to meet for any chemical.
    And the truth is that nearly everybody but the United 
States has taken strong regulatory action on formaldehyde. The 
State of California, the European Union, Australia, Canada and 
Japan have mandatory standards that are several fold stronger 
than the U.S. Government's voluntary standards for formaldehyde 
in wood products.
    Since 1997, the EPA has been trying to reassess 
formaldehyde. In 2004, this process was brought to a halt. 
Basically, EPA's political leadership was convinced that new 
science was right around the corner and they should delay a new 
IRIS listing for formaldehyde. At the same time, the Chemical 
Industry Institute of Toxicology, the CIIT, published its own 
risk assessment, which would say that formaldehyde standards 
should actually be weakened and not strengthened.
    It was fairly unprecedented. In 2004, when EPA's Air Office 
issued its new hazardous air pollutant standard for 
formaldehyde, it actually incorporated the CIIT assessment 
without any concurrence from EPA's scientists or from EPA's 
science advisory board. Now, I should say that rule was struck 
down in 2007 for procedural problems, other problems with the 
rule. But I think that this shows how, even in EPA's actions, 
this lack of progress with IRIS has been a problem.
    Then in 2005, Hurricanes Katrina and Rita flooded the Gulf 
Coast, and as you know, FEMA provided 120,000 travel trailers 
to the victims of those storms to serve as temporary housing. 
Unfortunately, these trailers contained unacceptable levels of 
formaldehyde. I think the story is very familiar to all of you, 
including the slow response by the Federal Government, the 
tragic consequences to the people who were living in those 
trailers, all of which in my view would have been unnecessary 
if EPA had done the right thing in the first place in terms of 
moving forward an appropriate scientific assessment.
    My point is that when you suppress this kind of information 
about what is the dose that makes the poison, there are serious 
consequences. We need to have an EPA whose scientists are free 
to communicate to us about risks. That is very, very important. 
When they are not free to do so, when there are impediments, 
when they are held hostage to these processes that go on 
interminably, the public's health does and will suffer.
    It is a complex and challenging process to do these IRIS 
reviews. It is also difficult to peer review these. The process 
of peer review needs to be done----
    Senator Boxer. You will have to conclude.
    Dr. Goldman. I will. It needs to be done in a scientific 
process and not through a process that is basically an 
invitation to back door involvement by parties who might be 
affected by the scientific assessment. I think that is what we 
have here.
    Thank you very much.
    [The prepared statement of Dr. Goldman follows:]



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Senator Boxer. I think that is the nub of what we have 
here. Thank you.
    Here is what we are going to do. I am going to give Senator 
Whitehouse and Senator Barrasso 7 minutes each to ask their 
final questions and sum up, and then I will take my turn and 
then we certainly thank this panel and the one before. This has 
been a very important hearing.
    Senator, 7 minutes, please.
    Senator Whitehouse. Thank you very, very much, Chairman.
    Let me start by asking Dr. Goldman about the, you described 
it as a back door process or a back door that the IRIS program 
creates in the process for influence by people who aren't 
proper scientists. I agree that it appears to deliberately 
create a vector for political interference. To what extent it 
will be used or not is open, but epidemiologically, you don't 
want to create that kind of vector, if you can, even in a 
political environment.
    But in response to that, Mr. Gulliford suggested that OMB 
had scientists on staff and that raised the implication that 
what is happening here with OMB is that they are adding to the 
science knowledge that EPA possesses. Based on your experience, 
how would you rate the scientific, particularly the science of 
chemistry, knowledge that is contained within OMB compared to 
that is contained within EPA with respect to the chemical 
process and its approval for use around humans?
    Dr. Goldman. For any one chemical, it is difficult to 
construct a panel of scientists who are qualified to peer 
review an assessment like the IRIS assessment. I cannot think 
of a single small group of scientists who are qualified to peer 
review each and every one of those, in addition to all the 
other science that the scientists at OMB supposedly are 
reviewing. No matter how good they are, it is not possible for 
them to have the depth and the breadth that you need to do that 
kind of review.
    How you add value through peer review is through something 
like the Science Advisory Board that EPA already has, which, by 
the way, is done out in the open. Those reviews are in the 
sunshine. Anybody can come and contribute, industry can 
contribute, others can come and contribute. And their arguments 
are considered on the merits, in terms of the science they are 
presenting. It is not political science. This is about science 
and the science advisory board process is the best way to 
accomplish that.
    Senator Whitehouse. Are you comfortable with the IRIS 
process as proposed at all?
    Dr. Goldman. Not at all. And I am very disturbed by the GAO 
report and seeing that EPA has increased the resources for that 
program fivefold over the last several years, with what looks 
to me to be about a four to fivefold decline in productivity. 
And now they are proposing to put more bells and whistles on 
the process. If nothing else, it is just poor management. There 
is very little output. More than half of the listings are out 
of date. And this is information that everybody needs, 
including industry.
    Senator Whitehouse. You mentioned formaldehyde, which is of 
particular interest. The Chairman knows very well my wife, I am 
a very over-married human. And as she well knows, my wife is a 
trained scientist. As a result of her education and the work 
she did as a marine biologist, she has had substantial exposure 
to formaldehyde. So that is, you ring a bell with me when you 
talk about formaldehyde.
    As I understood it, you said that the EPA began its process 
to evaluate the carcinogenic effects of formaldehyde back in 
1997. And it wasn't until 2004 that the process was closed to 
completion. It was then derailed by a finding, I guess by the 
Administrator himself, that there was new science around the 
corner.
    Was there any new science around the corner, or was he just 
waiting for the CIIT assessment? Was there, in the world of 
this science, was there some sort of tectonic shift that took 
place? Was there a new development that emerged?
    Dr. Goldman. Nothing has emerged since then. You are 
married to a scientist, so you know there is always new science 
around the corner. What one has to be committed to is periodic 
reevaluation, so that new science is incorporated. But no, 
nothing new has emerged since 2004, nothing.
    Senator Whitehouse. And then you said it was struck down in 
2007. Struck down by courts?
    Dr. Goldman. The rule was struck down, but not because of 
the risk assessment, but because of other things, such as some 
of the exemptions they tried to include.
    Senator Whitehouse. The Chairman has hosted hearings on the 
EPA batting record in the courts of this Country with their 
theories of why various anti-environmental policies should 
stand up. But here we go again. So as I summarize it, here we 
are in 2008. They started in 1997. Because of all this various 
folderol, we are effectively no place right now with respect to 
formaldehyde. How would you describe where we are in the 
process right now with respect to making a conclusion as to 
whether it is carcinogenic and what steps should be taken to 
protect public health?
    Dr. Goldman. I think we have to rely on the international 
assessment that came forth from IARC in 2004. We still don't 
have a voice from EPA on this. As far as I can tell, we are 
going to wait a long time before we will hear from EPA unless 
something is done to change this process.
    Senator Whitehouse. Thank you.
    Dr. Giudice, I would like to give you the opportunity to 
respond to Dr. Plunkett, who suggested in her testimony that 
the statistics that you shared with us were not supported by 
data. Just based on your resume, as the professor, indeed, 
Chair of the Department of Obstetrics, Gynecology and 
Reproductive Sciences at the University of California in San 
Francisco, I am not inclined to believe that you have made up 
statistics here in testimony before a Senate Committee. But I 
would like to give you the chance to buttress your assertions 
in light of her comments.
    Dr. Giudice. Thank you. I appreciate that opportunity.
    There is a reference by Bray and colleagues at the 
International Journal of Cancer in 2006, volume 118, pages 3099 
on trends in testicular cancer incidence. This is very recent 
and I would suggest that our colleagues look at that particular 
article.
    I am happy to provide the Committee with the written 
references for the other statistics that I quoted. Thank you.
    Senator Whitehouse. Madam Chair, thank you very much.
    Senator Boxer. Thank you.
    Before I call on my colleague, I want to put two things in 
the record, or three things. First, letters from more than 50 
national, State and local public health and environmental 
organizations expressing their opposition to the new 
interagency policy on IRIS, and also I am putting in, if there 
is no objection, recent news reports on this issue. Then 
second, Senator Whitehouse before you leave, this is in 
reference to your question and also the assertion by Dr. 
Plunkett that cancer is going down.
    How have childhood cancer incidence and survival rates 
changed over the years, National Cancer Institute, an increase 
over the past 20 years of children diagnosed with all forms of 
invasive cancer, from 11.5 cases per 100,000 in 1975 to 14.8 
cases per 100,000 children in 2004. And finally, also from the 
Cancer Institute, lymphoma, an estimated 74,000 new cases of 
lymphoma will occur in 2008. Since the early 1970's incidence 
rate for non-Hodgkins lymphoma has doubled. Just wanted you to 
know that before you left.
    [The referenced material was not received at the time of 
print.]
    Senator Boxer. Senator.
    Senator Barrasso. Thank you very much, Madam Chairman. I 
have two documents I would also like to read into the record, 
if I could, one from Synthetic Organic Chemical Manufacturers 
Association and another from the National Petrochemical 
Refiners Association.
    Senator Boxer. Without objection, Senator.
    [The referenced materialwas not received at the time of 
print.]
    Senator Barrasso. Thank you.
    Ms. Gellert, I appreciate your comments and your testimony 
as you are a cancer survivor, with placental cancer. My wife is 
a cancer survivor of breast cancer, which is obviously much 
more common, one in eight women, than placental cancer. Dr. 
Giudice, you are the professor. Placental cancer is fairly 
rare, isn't it?
    Dr. Giudice. Placental cancer is very rare, yes. It is much 
more common in Asia than it is in the United States. And the 
prevalence here I believe is something like 1 in 10,000 to 
15,000.
    Senator Barrasso. I think it is Taiwan with the greatest 
prevalence that I have studied, is it thought to be 
environmental in Taiwan?
    Dr. Giudice. It is unclear what the etiology is.
    Senator Barrasso. All right. I was curious how that all 
came about. Thank you.
    I notice that the two of you work pretty closely together. 
You are on the board of advisors of the UC San Francisco 
Medical center--no? All right. Then I must have a different 
Annette Gellert that is listed for the WELL Network.
    Ms. Gellert. I am a previous board member of the Obstetrics 
and Gynecology Research and Education Foundation at UCSF. That 
was a previous position. I am not currently on that board.
    Senator Barrasso. You are currently off the board.
    Ms. Gellert. I actually came to know about that board when 
I was at UCSF getting treated for the molar pregnancy that I 
had. My point was that I really, I don't know what caused it. I 
want to know what caused it. I want to know, I want more 
information so that I can, I want to know about my husband, 
too.
    Senator Barrasso. With his bladder cancer? My best thoughts 
are with him.
    Ms. Gellert. Yes. The known cause of that is industrial 
chemicals from every source that I could find.
    Senator Barrasso. And other causes, there are other----
    Ms. Gellert. Well, smoking, and he has never smoked a day 
in his life. Two risk factors are mentioned, one is smoking and 
the other is industrial chemicals.
    Senator Barrasso. OK. And then I understand, Doctor, that 
you are also an honorary board member of WELL Network?
    Dr. Giudice. I am. I just became, and when Ms. Gellert was 
on the OB/GYN Foundation Board at UCSF, this is close to 20 
years ago, and I joined UCSF two and a half years ago.
    Senator Barrasso. Thank you.
    Dr. Plunkett, I think we had kind of a back and forth, 
people responding to differences. Are there additional amounts 
of my time you would like to use to help clarify some of these 
matters?
    Dr. Plunkett. I just wanted to State that I am not 
asserting that cancer rates are going down. What I was trying 
to comment on was the fact that actually, I heard Ms. Gellert 
mention some statistics on rates and incidence. I had not, I am 
not aware of those particular numbers. I am concerned because I 
think there is a perception of the lay person and the public, 
and there is information out there that the scientists are 
aware of, and maybe we as scientists need to be better at 
getting that information out, so that the public is aware of 
what the real risks are, and what true incidence rates, what is 
the real incidence rate, how do you calculate it, how do you 
determine it, versus the numbers that may get thrown around in 
the popular press. That is all. That is really what my comment 
was about.
    I am not aware of the data that would support some of the 
numbers that were coming out. Certainly if there is such data, 
I would love to see it. I am just not aware of it. I am also 
not aware of the fact that the incidence rates have been going 
up to the level that has been asserted. That was the comment or 
the position I was trying to take.
    Senator Barrasso. You said in your testimony that the EPA 
currently has in place some methods for considering infants and 
children as separate exposed populations, apart from adults, 
allowing a risk assessment to consider and account for 
differences in exposure patterns. Could you elaborate a little 
bit on that?
    Dr. Plunkett. Yes. In the current methods that are used, 
where you do a risk assessment, you are looking at all the 
potential populations that can be contacted or exposed to the 
product. And if you have a product or chemical where you are 
worried about child exposure, such as if you had an infant, a 
bottle for an infant or you had some other product that the 
child might be contacting routinely, you can do child-specific 
exposure assessment on that. In addition to that, in the 
toxicity evaluation part of the risk assessment, for many, many 
chemicals you have data that has been collected in developing 
animals, reproductive and developmental toxicity studies, where 
you actually can assess what were the direct effects on a 
developing organism from exposure to that chemical.
    I know there are many chemicals that may not have that kind 
of data. But most of the ones we are talking about that have 
been raised at issue in this hearing, as I have heard it, are 
ones where that data is available.
    Senator Barrasso. Mr. DeLisi, you talked about the program 
in Europe, the REACH program. Is there a lot of hazard and 
exposure data available that has been gathered from that on 
different chemicals already?
    Mr. DeLisi. Nothing has been gathered yet. The pre-
registration period starts on the 1st of June, then you have 
until 2010 for more than a thousand tons a year of commerce and 
2013 for a hundred to a thousand and then 2018 for less than a 
hundred tons.
    Senator Barrasso. If we don't have any data yet from that 
REACH program, is it right to make comparisons between TSCA and 
the REACH program?
    Mr. DeLisi. I don't know how that would be possible.
    Senator Barrasso. I want to ask about some potential, Mr. 
DeLisi, in making the change in TSCA so that it shifts the 
burden of proving safety from the EPA to manufacturers. Would 
you recommend shifting that burden and how will that affect a 
manufacturer's ability to meet its needs of customers?
    Senator Barrasso. The burden needs to continue as it is, 
which is really shared. I was at a REACH conference last week, 
because REACH does talk about banning products, and frankly, 
the thing that most startled me was a representative of Rolls 
Royce trying to figure out how they could make a jet engine 
altogether without the use of nickel compounds, which could 
potentially occur in the EU, that nickel compounds would be 
banned. He literally said that, we can't figure out how to keep 
a jet engine together without the use of those kinds of 
materials.
    Senator Barrasso. Thank you, Madam Chairman.
    Senator Boxer. Well, we are going to close this panel out, 
and we have a few comments, a couple of questions.
    This has been a really important and far-reaching hearing. 
I want to thank each and every one of you. I think it has been 
good to have both sides on this panel. And frankly, on the 
other panel as well, the GAO saying that they investigated the 
EPA and found out politics is taking over the program, and EPA 
saying, oh, no, nothing could be further from the truth. Well, 
let's let the public judge and let's let my colleagues judge.
    But let me tell you what is going to happen, Mr. DeLisi and 
Dr. Plunkett, Ph.D. If we don't see action out of the EPA on 
listing these harmful chemicals, not only listing them but 
regulating them, Congress is going to do it. Senator Feinstein 
offered an amendment with me to ban phthalates. It passed 
overwhelmingly. You can see where Senate Whitehouse is coming 
from on formaldehyde.
    So don't think because you may be looking at this process, 
the weaker it gets, the stronger we are going to get. Because 
no Senator in the light of day, I shouldn't say no, most will 
not be able to take the heat of these dangerous chemicals. 
People are not stupid, they are smart, they understand, they 
see what is happening to their families. No one can tell them 
what is happening to their families, because they see it.
    So no one can say, oh, it is safe and cancer is going down 
or whatever you said, I am checking on your words. The fact is, 
we know the facts. Childhood cancer, up. I mean, it is a fact.
    So I just want to thank the doctors on the panel, the 
medical doctors on the panel. You took an oath to do no harm. 
And what you are doing through your work, your active work, 
which I praise so much, what you are doing is making sure that 
we are not harmed.
    And what is so intriguing about this hearing is that there 
are several issues raised, which is what we wanted. One is the 
current system, the way we regulate chemicals now and how it 
has failed us and how they have come up with four decisions 
when they were supposed to come with a hundred in the last 2 
years.
    So it has failed us, because the Administration has 
informally put into place the change in the IRIS program where 
they are allowing people to sit around a table secretly and 
give their views. And they have tainted and corrupted, and I 
use my words advisedly, they have corrupted the process of risk 
assessment. And the point is, it is not going to work, because 
the people won't allow it to happen.
    And you know, we met with a chemical company the other day 
who said that they are, and I am going to just tell you what 
happened, and I will direct this to Mr. DeLisi. We met with a 
chemical company that said they have invented substitutes for 
toxic chemicals, such as insulation without formaldehyde. And 
without strong regulations on the chemicals that present a 
risk, there is not a strong market for the safer product.
    So would you agree that sometimes regulation will spur 
invention, the genius of America, which is what Annette Gellert 
talked about, working with the private sector? Why is it my 
colleagues on the other side paint this picture of, every time 
we want to help the people of America get safer, oh, we are 
going to hurt the economy? That has never been true with 
environmental regulation. Never. We have had green industries, 
we have had green jobs. This is the scare tactics. So people 
get sick and they die and oh, we can't do anything about it, 
because it is going to hurt people's jobs. Well, you know, if 
you are really sick and you can't breathe, you can't come to 
work. Pretty basic.
    So Mr. DeLisi, I want to ask you, don't you think that when 
there is reasonable regulation that it presents an opportunity 
for business to come up with a safer product that you could 
then export to Europe, where there is obviously going to be a 
huge market for greener products? What do you think?
    Mr. DeLisi. Senator, unfortunately, I think it is a two-
edged sword. My Senator, Frank Lautenberg, this morning 
mentioned DDT. DDT is still in use in sub-Saharan Africa and 
lots of places, protecting people from the ravages of the 
mosquito-borne diseases. I would not want to be a regulator----
    Senator Boxer. OK, I am not asking you about DDT, because I 
know that story is always brought up. I am asking you about 
this man who came in from a chemical company and said they are 
ready to roll with a substitute for formaldehyde. I am asking 
you, yes or no, is there ever a case where reasonable 
regulation will lead to better, safer products? Yes or no?
    Mr. DeLisi. It can.
    Senator Boxer. Good.
    Mr. DeLisi. But if the cost of that insulation that he is 
producing is so large that nobody can afford it, that is a 
down, that is a problem for the consumers.
    Senator Boxer. Yes. But if I told you that your kid being 
exposed to certain levels of formaldehyde is going to get lung 
cancer, that the chances are, it is a very good chance, don't 
you think that is something we ought to move on and allow these 
substitutes? Don't you think that people in the Katrina housing 
there deserve to have accommodations that were free of 
formaldehyde? Don't you think?
    Mr. DeLisi. I am not an expert in formaldehyde, but if that 
has been proven, absolutely.
    Senator Boxer. Good. Well, we are working on it, here, we 
are getting there. I love agreement.
    Well, let me just say, again, do we have this? OK. All 
right. So we are going to put a lot of studies in the record, 
we will leave the record open for a week. And in summing up, 
here is where I think we are. We have an IRIS process that is 
the basis for many of our various environmental laws. That is 
how they, the Clean Water Act, the Safe Drinking Act, the 
Superfund, TSCA, they rely on--did I leave anything out?--Clean 
Air Act, they rely on the IRIS program. So IRIS cuts across.
    Now, we know the IRIS project has been corrupted. And the 
reason we know it is the GAO did an investigation and they are 
telling us that already, even without the new system in place, 
in effect, everything has basically stopped. And instead of 
listing and regulating 100, not listing, scratch that, instead 
of regulating 100 chemicals over 2 years, they have regulated 
four. So we are in a crisis. Annette Gellert was right, she 
used that word. We are in a crisis.
    If this goes forward, this process that Mr. Johnson, who 
refused to come here, somebody said no wonder he went to 
Australia, he doesn't want to sit across from me, I totally get 
it. But the fact of the matter is, he has a responsibility to 
be here and defend himself on this. This is a nightmare. This 
is a scandal.
    So we now have a circumstance where we are going to see a 
formalization of a process that puts politics in the center of 
regulating chemicals as Dr. Goldman alluded to, instead of pure 
science. This is a travesty. And it is happening under our 
noses.
    We are not going to stand for it. Either we are going to 
change things in the election or we are going to start banning 
these chemicals. Because there isn't one colleague that I know 
who is going to be able to stand the heat when there is proof 
about these chemicals.
    Now, I know Dr. Plunkett, you have defended people, your 
firm has, when they are sued, is that right?
    Dr. Plunkett. Most of my litigation work currently is in 
plaintiff's litigation, actually, not in defense.
    Senator Boxer. OK, so you bring suits against chemical 
companies?
    Dr. Plunkett. I don't bring suits. I have been an expert 
witness in litigation where suits have been brought against 
mainly pharmaceutical companies for injuries related to----
    Senator Boxer. So you have testified for the injured party?
    Dr. Plunkett. Yes, I have.
    Senator Boxer. Or for the company?
    Dr. Plunkett. For the inured party, in most cases.
    Senator Boxer. You do. So your firm is bent toward making 
sure that people who are injured by chemicals have a right to 
sue, and you come in and you testify on behalf of the injured 
person, is that correct?
    Dr. Plunkett. I act as an expert witness, to tell you what 
I do, I act as an expert witness, provide pharmacology and 
toxicology and FDA regulatory testimony related to the risks 
and hazards posed by a drug and whether or not that drug could 
have caused the injury in an individual.
    Senator Boxer. OK, well, I have some confusion, because 
your firm advertises, I have seen the advertising, that you 
would represent business in defending them. And you are saying 
you defend the plaintiffs, the harmed ones.
    Dr. Plunkett. I have worked on both sides. I have also done 
litigation where I have worked on behalf of industry as well. 
But in expert witnessing, currently in my litigation practice, 
all of my cases are plaintiffs cases at this point in time.
    Senator Boxer. OK, but, this firm----
    Dr. Plunkett. Integrative Biostrategies, yes.
    Senator Boxer. So this is wrong, it says it represents 
product liability, toxic tort, heavy metals, petrochemicals, 
pesticides and that is, my understanding is that they support 
the companies. That is not right?
    Dr. Plunkett. I do work on behalf of chemical companies in 
risk assessment and regulatory issues, yes.
    Senator Boxer. Oh.
    Dr. Plunkett. I have also worked on behalf of individual, 
for example, cities, other entities outside of industry. So I 
do both of those things.
    Senator Boxer. So cities that are sued?
    Dr. Plunkett. No. It is not all litigation work. In fact--
--
    Senator Boxer. Let's give an example of a city you have 
represented.
    Dr. Plunkett. For example, I have not represented, I have 
worked on behalf of a small city in Texas where there was a 
lead battery recycling facility located in town, right within 
the town. I worked with the city to help do a blood lead study 
on whether or not the industry was impacting the residents. I 
designed the study and helped implement the study for the city. 
So in that case, I was working on behalf of the children and 
the families within the city to determine whether there was a 
risk to their health.
    Senator Boxer. Well, good for you. Because then you ought 
to know about childhood cancer rates a little more.
    Dr. Plunkett. I----
    Senator Boxer. Here is the thing. We are dealing with life 
and death here. We have a witness who is experiencing a spouse 
who has bladder cancer. She said the two causes that she has 
been able to learn, because they don't know why, are smoking, 
which he never did, and exposure to industrial chemicals. We 
need to find out these things. We need to know, frankly. Our 
Government needs to know, so you don't have to go off to Texas 
and figure out what this, I mean, we ought to have the 
information of what these batteries do.
    Dr. Plunkett. I would agree with you, Senator, that we need 
to know about the chemicals. My only point, the reason I am 
here today is to say that I believe there are risk assessment 
methods currently in place that allow us to determine which 
chemicals truly are risks, based on hazard information which we 
have, but also exposure and the actual information from the 
science on the responses in individuals.
    Senator Boxer. Right. And I will tell you, what we have in 
place is the IRIS program.
    Dr. Plunkett. We have more than that in place, I would 
argue.
    Senator Boxer. That is the basic, well, you could argue it. 
But the fact is, every single agency has told us that the IRIS 
program is the program that is the basis for their decisions, 
OK? So the IRIS program is the basis for regulation under the 
Clean Air, Clean Water, and Superfund and all the things that I 
mentioned before.
    So the IRIS, the integrity of that program is at stake 
here. That is why, when the GAO tell us the program is a shadow 
of its former self, now, to get to the issue of REACH is very 
important. Because, Mr. DeLisi, I want you to explain something 
to me. My understanding is a lot of chemical companies do 
business in Europe. Is that correct, would that be your 
understanding?
    Mr. DeLisi. Yes.
    Senator Boxer. And they will have to conform with REACH, is 
that correct?
    Mr. DeLisi. Or they can make a decision to stop doing 
business in Europe.
    Senator Boxer. Exactly. And what do you think people will 
do? Do you think they will walk away?
    Mr. DeLisi. Some will.
    Senator Boxer. Well, I would argue they won't walk away. I 
will argue that they will want to, because this is a global 
marketplace. And with the dollar falling as it is, this is the 
moment where our business are really, at least beginning to see 
an increase in their exports. So I would argue that they would.
    And I would further say, going back to my initial point, 
that when we have this concern, and it is expressed in 
legislation, you are going to have an impetus for these 
substitutes. Now, you are very right, maybe they will cost a 
little more. I would submit to you, if you ask the American 
people, if you could reduce the rate of childhood cancer, we 
could go into what those cancers are, by taking the following 
steps, having to pay 35 cents more for a solvent, or a dollar 
more for a different type of cleanser, I would be people would 
be glad to do that.
    So from my perspective, I think it is very shortsighted for 
business to put their head in the sand and act as if nothing is 
going to change. Because here is my point. If we don't see a 
coming together here and I will get back to what Annette 
Gellert said, which is, working together with business and 
Government and the non-profit community, if we don't see that 
happening, I am just saying, colleagues of mine are going to 
take matters into their own hands and you are going to see 
banning of these chemicals and banning of these products. And 
you will not know what is going to hit you next.
    So I think it is in the best interest of business to work 
with us in a way where we do have an open, transparent process 
here, where we don't have the regulation of a chemical such as 
formaldehyde get bogged down, as Dr. Goldman said, when we were 
just there at coming up with the regulation, Mr. Johnson pulled 
it down. That is not going to sit well, and you are going to be 
far worse off. You are going to have no certainty because you 
are going to have people going to the floor of the Senate 
saying, my community, so many people got this type of cancer. 
And you are going to really have more of a problem.
    So I would urge us to work together. I think the message of 
the Wellness Foundation, is it the Foundation?
    Ms. Gellert. The WELL Network.
    Senator Boxer. The WELL Network. That is a great message. 
We are all in this together. This shouldn't be one side arguing 
with another. We have everything to gain when we have safe 
products. We have a confident community that won't start 
boycotting certain products. And I just think do no harm is our 
first thing we should think about, do no harm. But second, make 
things better.
    I think we ought to look at what Europe is doing. I think 
we ought to realize that it is in the best interest of our 
businesses to learn to work with these restrictions and see how 
we can have a system, frankly, that isn't different. Because I 
think that another thing Annette Gellert said is right on the 
mark, we don't want America to be the dumping ground for 
dangerous products.
    Because here is what is going to happen, I will tell you 
right now, our people will start importing products from Europe 
in numbers. And by the way, it will be a big business. Somebody 
will get a license, they will bring in these safe products and 
you will not be able to compete because the American people 
understand that some of these chemicals are dangerous. And if 
they have an opportunity to buy a green product, they are going 
to do it.
    So I think this could be a win-win for business if we have 
a little bit of a different attitude. Otherwise, you are going 
to have competition from abroad you never thought you had. I 
just think that is not good for business and it is not good for 
our people. So this has been a heart-felt hearing. I really 
thank all of you for being here, all of you, with your 
perspectives. I respect all the perspectives, but I think at 
the end of the day when our people are healthy, we are a better 
Nation for it.
    Thank you very much, and we stand adjourned.
    [Whereupon, at 12:35 p.m., the committee was adjourned.]

          Statement of Hon. Benjamin L. Cardin, U.S. Senator 
                       from the State of Maryland

    Madame Chairman, thank you.
    The mission of the Environmental Protection Agency is to 
protect human health and the environment. The Integrated Risk 
Information System (IRIS) Program is a manifestation of that 
part of the EPA's mission which includes the evaluation and 
regulation of toxic chemicals.
    With over 500 chemicals listed, and over 9,000,000 queries 
to the IRIS data base, IRIS is a valuable resource both within 
the U.S. and around the world in understanding the potential 
human effects that exposure to the listed chemicals might 
cause. The quantitative information contained in IRIS allows 
IRIS to be a component in the regulatory process of many states 
and even other countries. The regard with which this data base 
is held is a tribute to the tireless efforts of EPA scientists 
in evaluating the risks of the listed chemicals. In order to be 
both useful and credible, the process to list a chemical in the 
IRIS data base must be unbiased, science-based, timely, and 
transparent.
    In the last few years, despite increases in IRIS personnel, 
a backlog of IRIS assessments have developed. This backlog is 
due, in part, to new OMB-managed, interagency reviews and due 
to delays in completion of assessments to await new research.
    Earlier this month, the EPA released a revised assessment 
process for IRIS. This revised process concerns me as it will 
allow far less transparency into the decision making process.
    The new assessment process conflates the EPA's science 
position on an assessment with the EPA's science policy 
position. Assessment findings should inform policy, not be 
informed by policy.
    Finally, this revised assessment process continues the 
recent practice of OMB's having a role in the process as well 
as establishing a new, interagency review process for IRIS. 
This change potentially compromises the integrity of IRIS by 
allowing those agencies that may have a stake in the EPA's 
assessment be able to influence that very assessment.
    I am pleased to welcome Dr. Lynn R. Goldman, a professor of 
environmental health at the Johns Hopkins Bloomberg School of 
Health. Dr. Goldman has served as EPA Assistant Administrator 
for Prevention, Pesticides and Toxic Substances. Dr. Goldman's 
work in reducing the risk of chemicals and pesticides to the 
health of the public in general, and children in particular, is 
noteworthy.
    I look forward to hearing Dr. Goldman's testimony and that 
of all of the other panelists today as we conduct this 
oversight hearing into EPA's toxic chemical policies.
    Public health and environmental policy decisions must be 
rooted in objective scientific assessments. These assessments 
must be timely and made using the best practices possible.
    Thank you Madame Chairman.



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